Product code DWJ— Cardiovascular
Altrix Precision Temperature Management System
- Classification name
- System, Thermal Regulating
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Total cleared
- 161
- First cleared
- Most recent
FDA classification definition
“If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).”
Market context for product code DWJ
FDA has cleared devices under product code DWJ between 1976 and 2026, filed by 77 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2014
- 2013
- 2012
- 2011
Top applicants under product code DWJ
Adverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DWJ
1–100 of 161- K262089 — Disposable Warming Blanket
- K261437 — Mistral-Air® Warming System
- K260278 — ThermAffyx(TM) Patient Safety System
- K260903 — Hot Pink Pad Warming System
- K252861 — Warming System
- K251974 — Arctic Sun Temperature Management System (Model 5000)
- K242964 — Celsi Warmer
- K243942 — Arctic Sun Stat Temperature Management System
- K232627 — HotDog Warming Mattress + Return Electrode
- K232502 — Cocoon Convective Warming System, Model CWS7000
- K231211 — Medline ComfortTemp Patient Warming System
- K232638 — FilteredFlo Warming Blankets
- K232844 — The IQoolTM System
- K232508 — Barrier EasyWarm Active Self-Warming Blanket
- K231596 — IOB Temperature Management System
- K230866 — HotDog Warming Mattress + Return Electrode
- K221669 — IOB Warming Blankets
- K220941 — HotDog Temperature Management System
- K210605 — 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation
- K210603 — 3M Bair Hugger Temperature Management System (Model 675)
- K203085 — NOVA Patient Warming System
- K201779 — HotDog Temperature Management Controller
- K202197 — Astopad Patient Warming System
- K200446 — STERIS Patient Warming System
- K200225 — Arctic Sun Stat Temperature Management System
- K190221 — IOB Warming Blankets
- K181671 — Cocoon Convective Warming System
- K180834 — Altrix Precision Temperature Management System
- K181699 — Level 1 Convective Warmer
- K180375 — The IQoolTM Warm System
- K171373 — 3M Bair Hugger Model 675 Total Temperature Management System
- K171149 — Altrix Temperature Management Wraps
- K171234 — Mistral-Air Warming Unit
- K162679 — IOB Temperature Management System
- K162562 — OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY
- K152266 — Altrix Precision Temperature Management System
- K161602 — Arctic Sun Temperature Management System
- K142702 — Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
- K140078 — TECOTHERM NEO (T NEO)
- K141686 — EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY
- K140635 — COCOON CONVECTIVE WARMING SYSTEM
- K132048 — BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET
- K132454 — VITAHEAT PATIENT WARMING SYSTEM
- K131361 — WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
- K123083 — COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT
- K123946 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS
- K113705 — PINTLER PATIENT WARMING SYSTEM
- K121720 — WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM
- K120849 — HYBRID ARCTICGEL PAD
- K121669 — WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
- K120081 — NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
- K112488 — HOTDOG PATIENT WARMING SYSTEM
- K102856 — SIROCCO THERMAL REGULATING SYSTEM
- K110104 — BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
- K100585 — MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
- K102112 — CRITICOOL PRO
- K093244 — UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX
- K101148 — WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS
- K093694 — GERATHERM UNIQUERESC
- K101589 — BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
- K101092 — ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
- K101705 — MISTRAL-AIR WARMING SYSTEM
- K094056 — HOTDOG MULTI FUNCTION CONTROLLER
- K092807 — HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103
- K083336 — LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL
- K083662 — CRITICOOL
- K083135 — MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002
- K073712 — SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100
- K080763 — TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT
- K072513 — DM-EMG
- K071918 — CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002
- K071341 — MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
- K070112 — RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM
- K061902 — COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1
- K062794 — PRN THERMALCARE, MODEL 3000
- K061513 — LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET
- K051278 — GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)
- K051336 — GERATHERM SOS-RESCUE BAG
- K052392 — HOT DOG PATIENT WARMING SYSTEM
- K051419 — INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1
- K060865 — BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850
- K053645 — MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
- K051097 — GERATHERM SOS-RESCUE BLANKET
- K031728 — KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET
- K041686 — BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
- K040911 — VITALHEAT
- K040440 — HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS)
- K040632 — SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000
- K033021 — KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS
- K024128 — ALLON 2001 VERSION 5
- K023934 — RAPID THERMAL EXCHANGE SYSTEM
- K022903 — CHILLBUSTER
- K014210 — PALMO THERMOREGULATION INTERFACE ACCESSORY
- K021473 — BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
- K011859 — KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS
- K020604 — WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300
- K014121 — WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860
- K011907 — SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
- K010338 — ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200
- K003368 — ACROTHERM
Data sourced from openFDA. This site is unofficial and independent of the FDA.