Product code BTL— Anesthesiology
MOVES SLC
- Classification name
- Ventilator, Emergency, Powered (Resuscitator)
- Device class
- Class 2
- Regulation
- 21 CFR 868.5925
- Advisory panel
- Anesthesiology
- Total cleared
- 100
- First cleared
- Most recent
Market context for product code BTL
FDA has cleared devices under product code BTL between 1977 and 2025, filed by 46 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- 2025
- 2023
- 2021
- 2020
- 2019
- 2018
- 2017
- 2015
- 2014
- 2013
- 2011
- 2010
- 2009
- 2008
- 2007
Top applicants under product code BTL
Adverse events under product code BTL
product code BTL- Death
- 8
- Malfunction
- 3,256
- Other
- 1
- Total
- 3,265
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 BTL
- K242769 — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
- K221634 — Oxymag - Transport and Emergency Ventilator
- K202219 — VORTRAN GO2VENT with PEEP Valve
- K193191 — MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
- K182956 — Puffin Lite Infant Resuscitation System
- K173373 — SafeT T-Piece Resuscitator
- K161420 — MOVES SLC
- K162968 — VORTRAN GO2VENT
- K141595 — O-TWO E700,O-TWO E600,O-TWO E500
- K142096 — T-PIECE RESUSCITATOR
- K140049 — MOVES SLC
- K140707 — LIFEBORNE INFANT RESUSCITATOR
- K131098 — EMERGENCY PORTABLE VENTILATOR
- K132021 — AHP 300, EMERGENCY PORTABLE VENTILATOR
- K132759 — VENTRAIN
- K131877 — SAVE II, SAVE II BASIC
- K123957 — PNEUPAC PARAPAC PLUS
- K112783 — MANUJET III
- K102542 — RESUSCI FLOW; RESUSCI FLOW 104
- K093862 — CAREVENT HANDHELD CPAP SYSTEM
- K093913 — MERCURY MEDICAL T-PIECE RESUSCITATOR
- K093261 — MOVES
- K092085 — ISPIRA RESUSCITATION UNIT
- K090356 — EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
- K083507 — BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
- K083385 — MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
- K081330 — CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
- K080063 — MASS CASUALTY VENTILATOR, MODEL MCV100
- K080692 — MACS CPAP SYSTEM
- K073261 — VAR MONITOR
- K072214 — PORTABLE VENTILATOR, MODEL EPV-100
- K071527 — PNEUPAC VR1 AIR MIX
- K071221 — SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12
- K070636 — AUTOVENT 4000 WITH CPAP
- K070120 — AUTOVENT MODEL 4000
- K070210 — GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
- K051476 — UNI-VENT MODEL 73X
- K051469 — CAREVENT ATV+ AND CAREVENT MRI
- K051889 — CAREVENT CA AND DRA
- K051322 — PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS
- K043495 — BABYPAC
- K041473 — VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
- K040090 — COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS)
- K032386 — UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
- K030803 — PARAPAC 200D TRANSPORT, MODEL V200D
- K021841 — COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER
- K020899 — PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D
- K021520 — EMT-CPAP
- K001430 — RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
- K991785 — MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
- K991195 — CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
- K983857 — AUTOVENT 1500
- K983643 — GENESIS BLS
- K983705 — EMT RESUSCITATOR
- K983785 — AUTOVENT 1000
- K982225 — SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504
- K973975 — RESPIRTECHPRO
- K960515 — PARAPAC
- K944349 — OXYLATOR EM-100
- K951126 — DRAGER MEDICAL AIR COMPRESSOR
- K944397 — BNOS MICROVENT, MODEL AC AND MODEL AO
- K941870 — LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100
- K941871 — LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100
- K931473 — IMPACT MODEL 753
- K924272 — MEDIRESP III
- K932199 — LSPI AUTOMATIC VENTILATOR, MODEL AV3000
- K932200 — LSPI AUTOMATIC VENTILATOR
- K932170 — FLYNNR GENESIS II A/C, A/O AND IDLH
- K920910 — OXYGEN POWERED RESUSCITATOR FOR CPR
- K921926 — JET VENTILATOR/JETTING DEVICE
- K913039 — FLLYNN(R) GENESIS AC
- K915564 — SPIROS
- K910699 — LIFE-02 (NON-REFILLABLE CYLINDER)
- K910434 — LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL
- K910435 — LIFE OXYGENPAC 6/12 LPM
- K911261 — ERA 2000A
- K904920 — AMBU MATIC AUTOMATIC RESUSCITATOR
- K910201 — LIFE O2
- K905697 — POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE
- K901846 — OHMEDA - LOGIC 07A TRANSPORT VENTILATOR
- K895946 — BIVONA CARDEN INTERMITTENT JETTING DEVICE
- K892885 — RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR
- K884089 — ERA 2000 EMERGENCY RESUSCITATOR
- K882833 — THE BERG RESUSCITATION APPARATUS
- K870424 — LSP AUTOMATIC VENTILATOR, MODEL 456
- K874656 — AUTOMATIC VENTILATOR AV2000
- K863410 — PATIENT VALVE WITH AIR ENTRAINMENT
- K862830 — MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR
- K862192 — RESUSCITATOR MODELS 10400/10500/10600/10700/10800
- K861272 — IMPACT MODELS 701, 702 AND 703
- K860077 — SG-066 OXYGEN ENRICHMENT KIT
- K855092 — LIFE CORP. OXYGEN PAC
- K853971 — REGULATOR-INHALATOR SYSTEM
- K851337 — 502 RESUSCITATORY INHALATOR VALVE
- K841893 — MAXAMAN
- K830404 — RAD VALVE
- K800456 — EMERGIENCY RESUSCITATOR/INHALOR W/ASPIR.
- K792453 — PNEUPAC OXYGEN THERAPY UNIT
- K780168 — PARAMEDIC O2 KIT
- K771299 — EMERGENCY OXYGEN RESUSCITATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.