Product code BTY— Anesthesiology
SENTRYSUITE PRODUCT LINE
- Classification name
- Calculator, Predicted Values, Pulmonary Function
- Device class
- Class 2
- Regulation
- 21 CFR 868.1890
- Advisory panel
- Anesthesiology
- Total cleared
- 64
- First cleared
- Most recent
Market context for product code BTY
FDA has cleared devices under product code BTY between 1978 and 2026, filed by 40 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
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2017
- 2016
- 2012
- 2011
- 2010
- 2009
- 2008
- 2007
Top applicants under product code BTY
Recent clearances under product code BTY
- K260242 — CPETWise Platform
- K242809 — Ascent Cardiorespiratory Diagnostic Software
- K223629 — SpiroSphere, SpiroSphereECG, CardioSphere
- K231561 — Pulmonary Function Tester, Model: A9
- K222982 — Virtus Metabolic Monitor
- K221030 — Model 9100 PFT/DICO
- K202754 — MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
- K190800 — Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
- K181912 — Ascent Cardiorespiratory Diagnostic Software
- K173937 — SpiroSphere
- K161534 — EasyOne Pro Respiratory Analysis System
- K150888 — Shape-HF Cardiopulmonary Testing System
- K122699 — SENTRYSUITE PRODUCT LINE
- K120635 — EASYONE PRO RESPIRATORY TESTING DEVICE
- K113813 — SENTRYSUITE PRODUCT LINE
- K111053 — SENTRYSUITE PRODUCT LINE
- K091428 — EASYONE PRO RESPIRATORY ANALYSIS SYSTEM
- K090722 — SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
- K082539 — MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
- K080510 — VIP PULMONARY FUNCTION SYSTEM
- K080734 — FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
- K071753 — MASTERSCREEN PNEUMO & MASTERSCOPE
- K062011 — MODIFICATION TO FLOWSCREEN
- K040549 — COSMED PONY FX
- K031194 — SPIROSOFT
- K020745 — COSMED MICROQUARK
- K993641 — METALYZER, MODEL 2; METALYZER, MODEL 3
- K000648 — SPIRO PRO
- K981366 — STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES
- K980094 — MODIFICATION TO THE OXYCONALPHA
- K961252 — DSXL DIFFUSION SPIROMETER
- K942230 — OXYCON-ALPHA
- K942211 — VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
- K932744 — FLOWSCREEN
- K933839 — MASTER SCREEN PNUEMO
- K933511 — UPGRADED SPIROMETER ST-90
- K921309 — MODEL 508 PATIENT MONITOR
- K932278 — PFM PROFESSIONAL 7000 SPIROMETER
- K930085 — VITALOGRAPH DATA STORAGE SPIROMETER
- K911358 — CMD/DLCO DIAGNOSTIC SPIROMETER
- K892705 — EBS2605 INFANT HUGGER
- K894667 — MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP
- K883008 — PULMONARY FORCED FLOW SYSTEM (PUFFS)
- K881122 — UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.
- K864836 — L.A.P. SPIROMETER
- K864087 — PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM
- K863087 — SPIROLOOP-PULMONARY EXERCISE SYSTEM
- K861487 — ST-90 SPIRO ANALIZER
- K861486 — SPIROMETRY MODULE
- K855068 — SPIROMETER, MODEL TS-500 PART #SLZ7534
- K855069 — SPIROMETER TS-400 SLZ 7547
- K854745 — CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM
- K853433 — ELF
- K850045 — SPIROMETRICS 2453 & SMI III
- K823771 — SPIROTECH 300
- K823683 — VITALOGRAPH PFT PRINTER
- K821712 — INFORMED REMOTE FIELD UNIT MODEL IFM1000
- K812849 — PTT-200 TELEPHONIC PULMONARY TRANSMITT
- K812850 — PTT-200 PULMONARY RECEIVER/MICROPROCES
- K812792 — PFT SCREENER (SYSTEM 1100)
- K810712 — ELECTRONIC SPIROMETER MODEL MFR-8100
- K803053 — APEXLINE OF PULMONARY FUNCT. INSTRUM.
- K790579 — MEDISTOR II
- K780584 — PULMONARY FUNCTION TESTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.