Atlas FDA

BZO

88 FDA 510(k) clearances · Product code

35 daysmedian time to decision
90 days90th percentile
88clearances measured

FDA profile

Official device name
Set, Tubing And Support, Ventilator (W Harness)
Device class
Class I (low risk)
Regulation
21 CFR 868.5975
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2021: 52 · 2022: 66 · 2023: 37 · 2024: 45 · 2025: 71 · 2026: 131
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
UNICOR, INC. CORRUGATED TUBING (K953784)Unicor, Inc.1995-09-19
UNICOR, INC. VENTILATOR HOSES (K953785)Unicor, Inc.1995-09-18
PRIMA VENTILATOR HOSES (K952010)Prima, Inc.1995-05-22
PRIMA VOLUMN VENTILATORSS (K952022)Prima, Inc.1995-05-22
PRIMA CUSTOM ANESTESIA CIRCUIT (K952012)Prima, Inc.1995-05-22
PRIMA BREATHING BAGS (K952011)Prima, Inc.1995-05-22
INFANT FLOW SYSTEM (K945740)Hamilton Medical, Inc.1995-03-23
PRIMA, INC. CORRUGATED TUBING (K944531)Prima, Inc.1994-12-02
VENTILATOR HOSE (K942569)Med-Plastics Intl., Inc.1994-06-10
VOLUME VENTILATOR (K942572)Med-Plastics Intl., Inc.1994-06-10
TUBE, INHALER OXYGEN (K935582)Puritas Health Care, Inc.1994-01-14
STAR BREATHING CIRCUITS (K934753)Infrasonics Corp.1993-10-27
PRECISION MED PRODUCTS LTD. VENTILATOR HOSE (K932706)Precision Med Products, Ltd.1993-07-23
PRECISION MED PRODUCTS LTD VOLUME VENTILATORS (K932712)Precision Med Products, Ltd.1993-07-22
VOLUME VENTILATORS (K932560)Life Shield Healthcare Products, Inc.1993-07-22
VENTILATOR HOSES (K932563)Life Shield Healthcare Products, Inc.1993-07-16
CLEVELAND TUBING, INC. VENTILATOR HOSES (K932119)Cleveland Tubing, Inc.1993-06-23
DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED (K922479)Intertech Resources, Inc.1992-10-30
GAS SAMPLING KIT MODIFICATION (K921510)Respiratory Support Products, Inc.1992-06-11
UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION (K911328)Intertech Resources, Inc.1991-08-15
NEONATAL VENTILATOR CIRCUIT (K903083)Hudson Respiratory Care, Inc.1990-12-27
EXTENDED LIFE CIRCUITS (K903055)Pharma Systems, Inc.1990-11-09
FLOCARE F (K903404)Flocare Medical1990-09-25
TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE (K896439)Ventlab Corp.1990-01-09
SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT (K895853)Sechrist Industries, Inc.1989-12-22
CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 (K893760)Nova-Ventrx1989-08-10
CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE) (K890822)Ventlab Corp.1989-05-05
OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING (K890011)Life Design Systems, Inc.1989-03-20
PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT (K884525)Intertech/Ohio1988-12-16
QUICK CONNECT T ADAPTOR (K882341)Thayer Medical Corp.1988-07-18
LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY (K880959)Lifeguard Medical Products, Inc.1988-04-14
BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES (K880637)Baxter Healthcare Corp1988-04-11
BABYFLEX PATIENT CIRCUIT (K874559)Airoflex Medical, Inc.1987-12-21
PORTABLE VENTILATOR PATIENT CIRCUIT (K873900)Puritan Bennett Corp.1987-10-30
REUSEABLE BREATHING TUBES (K873927)Dryden Corp.1987-10-20
MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT (K863756)Nova-Ventrx1986-11-13
RAINCOAT (K863910)Artec Environmental Monitoring Division1986-10-20
PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS (K863033)Intertech/Ohio1986-08-20
END TIDAL CO2 SAMPLING CIRCUIT (K860659)Life Design Systems, Inc.1986-04-17
GAS SAMPLING KIT (K861286)Respiratory Support Products, Inc.1986-04-11
DISPOSABLE VENTILATOR CIRCUITS (K860879)Dhd Medical Products Div. Diemolding Corp.1986-03-20
VENTILATOR CIRCUITS (VARIOUS TYPES) (K860880)Dhd Medical Products Div. Diemolding Corp.1986-03-20
L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT (K850151)Life Products, Inc.1985-07-19
CO-AX VENTILATOR CIRCUIT (K850600)Nova-Ventrx1985-05-02
SAF T FLO VENTILATOR TUBING (K850703)Bivona Medical Technologies1985-03-25
L100D PATIENT CIRCUIT DUAL LINE (K844290)Life Products, Inc.1985-01-10
PATIENT BREATHING CIRCUIT (K843036)Infrasonics Corp.1984-08-15
AVATRON UNIVERSAL ADULT VOL. VENTILATOR (K842778)Avatron, Inc.1984-07-26
AVATRON DISPOSABLE I.P.P.B. CIRUCIT (K842389)Avatron, Inc.1984-06-26
PATIENT TUBING HYTREL SIEMENS-ELEMA (K841657)Siemens Elema AB1984-05-23
MASS SPECTROMETER INTERFACE (K841722)Dryden Corp.1984-05-14
VENT-WELL VENTILATOR TUBING (K841378)Airmed Corp.1984-05-02
THREE PORT SENSOR MANIFOLD (K841637)Dryden Corp.1984-05-02
VENTILATORY FREQUENCY MONITOR (K834569)Cryo Corp.1984-03-30
VOLUME VENTILATOR CIRCUIT W/WATER TRAP (K834570)Airlife, Inc.1984-03-05
COAXIAL VOL. VENTILATOR CIRCUIT (K833459)Airco/Ohio Medical Products1984-01-10
UNIVERSAL VOL. VENTILATOR 72 #1626 (K832681)Hudson Oxygen Therapy Sales Co.1983-09-26
TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURA (K830923)Cygnus Research Corp.1983-05-03
TEMP-CHECK ADAPTOR, TEE-CONFIGURATION (K830922)Cygnus Research Corp.1983-05-02
TEMP-CHECK ADAPTOR, Y-CONFIGURATION (K830921)Cygnus Research Corp.1983-05-02
BE #16 - MANIFOLD (K823481)Instrumentation Industries, Inc.1982-12-22
DISPOSABLE ADULT VO. VENTILATOR CIRCUIT (K823271)Intec Medical, Inc.1982-12-22
MODUFLEX NEONATAL VENTILATOR SET (K823479)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-12-15
RESPIRATORY CIRCUIT ADAPTOR (K823287)Thoratec Laboratories Corp.1982-12-09
INSPIRON NEONATAL VENTILATOR CIRCUIT (K821064)C.R. Bard, Inc.1982-05-03
UNI-SET (K820128)Inhalation Therapy Equipment, Co.1982-03-23
3M VOLUME VENTIATOR CIRCUIT (K820131)3M Company1982-01-28
DISPOSABLE NEONATAL VENTILATION CIRCUIT (K813384)Intec.1982-01-07
PEDIATRIC VENTILATOR CIRCUIT 2C7131 (K813155)Travenol Laboratories, S.A.1981-12-09
VENTILATOR CIRCUIT (K812774)Hudson Oxygen Therapy Sales Co.1981-10-23
BENNETT VOLUME VENTILATOR CIRCUIT (K812773)Ideal Medical, Inc.1981-10-23
RAIN-X (K812737)Nova-Ventrx1981-10-23
LIFELINE IPPB SET-UP (K810341)Todd Industries, Inc.1981-03-17
CAM-10 RESPIRATORY HOSE ASSEMBLIES (K801859)Lifecare Services, Inc.1980-09-09
NEONATAL BREATHING CIRCUIT SYSTEM (K801087)Isothermal Systems, Inc.1980-05-23
CIRCAPAK (K792268)Respiratory Care, Inc.1979-11-27
TWO-PIECE I.P.P.B. MANIFOLD-WITH RIGHT (K792030)Airlife, Inc.1979-10-30
CIRCUIT, BREATHING (W/ CONNECTOR, ADAPT, (K792047)Airlife, Inc.1979-10-30
CIRCUIT, BREATHING W/WO NEBULIZER (K791761)Airlife, Inc.1979-10-26
Y & ELBOW W/WO PORTS (K791856)Airlife, Inc.1979-09-26
MANIFOLD/NEBULIZER BREATHING PRODUCTS (K791469)Hospitak, Inc.1979-08-28
PIGGYBACK BREATHING CIRCUIT (K791034)Vital Signs, Inc.1979-06-15
RAIN-X (K791060)Sherwood Medical Co.1979-06-15
VOL. VENTILATOR SETUP W/OUT NEBULIZER (K772069)Inspiron Corp.1977-11-15
CORRUGATED TUBING #770 & 771 (K770593)Surgicot, Inc.1977-04-19
CORRUGATED TUBING, 770 & 771 (K770581)C.D. & F. Corp.1977-04-19
TUBING, AEROSAL, DISPOSABLE (K770354)Inhal-O-Tech Medical Plastic1977-03-16
MECK/MILLER VENTILATION TUBE HARNESS (K760993)Timeter Instrument Corp.1976-12-09

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