Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Airlife, Inc. — Predicate Candidate Screening

76 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

25 daysmedian FDA review time
67 days90th percentile
76clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K834573AQUA TRAPAirlife, Inc.1984-03-05670
K834570VOLUME VENTILATOR CIRCUIT W/WATER TRAPAirlife, Inc.1984-03-05670
K834077SINGLE USE NEBULIZER-ADJUST-AIR ENTRAINAirlife, Inc.1983-12-12170
K833196VOLUME VENTILATOR CIRCUIT-NEBULIZERAirlife, Inc.1983-11-03450
K833197TRACH SWIVE/CONNECTORAirlife, Inc.1983-10-28390
K832725DUAL DIAL VENTURI STYLE MASKAirlife, Inc.1983-09-20390
K831246WHISTLER IN-LINE PRESSURE RELEASE VALVEAirlife, Inc.1983-07-26990
K830895SINGLE USE NEBULIZER, ADJUST. AIR-Airlife, Inc.1983-04-28380
K830896HUMIDIFIER, WITH OR WITHOUT ADAPTERAirlife, Inc.1983-04-18280
K821129AIRLIFE NEBULIZER HEATERAirlife, Inc.1982-05-18280
K821128DISPOSABLE THERMOPLASTIC RUBBER MOUTHAirlife, Inc.1982-05-13230
K812067INSPIRATORY FORCE PRESSURE ADAPTORAirlife, Inc.1981-08-12220
K812066PERCENTO MASK, PEDIATRIC, UNDER-THE-CHINAirlife, Inc.1981-08-03130
K811908IMV MANIFOLDSAirlife, Inc.1981-07-16150
K811890DISPOSABLE TRACH T OXYGENATORAirlife, Inc.1981-07-15140
K811711PEDIATRIC OXYGEN MASKSAirlife, Inc.1981-07-01140
K811708UNIVERSAL ADAPTER SYSTEM-U/ADAPITAirlife, Inc.1981-07-01150
K811161HUMIDIFIER W/ OR W/OUT ADAPTORAirlife, Inc.1981-06-24570
K810947AIR ENTRAINMENT TRACH TAirlife, Inc.1981-06-02560
K810946ADULT & PEDIATRIC TRACHEOSTOMY MASKSAirlife, Inc.1981-06-02560
K802852HUMIDIFIERAirlife, Inc.1981-02-261060
K802663BLOW-BY-SET-UP CONNECTOR-AIRWAYAirlife, Inc.1980-11-12150
K802477MISTY NEBULIZERAirlife, Inc.1980-10-31260
K802323PEDIATRIC OXYGEN OR AEROSOL MASKS,Airlife, Inc.1980-10-03100
K801875CIRCUITS, BREATHING W/CONNECTORS, ADAPTAirlife, Inc.1980-08-1490
K801252NEBULIZER WITH AIR ENTERTAINER & ETC.Airlife, Inc.1980-06-0470
K801191ANESTHESIA BREATHING CIRCUITSAirlife, Inc.1980-05-2890
K801190OXYGEN TUBING (CRUSH RESISTANT)/VINYL TPAirlife, Inc.1980-05-2340
K800990TRACH MIST UNIT W/OR WITHOUT ELBOWAirlife, Inc.1980-05-08140
K800498ADULT ANESTHESIA BREATHING CIRCUITS . .Airlife, Inc.1980-03-25210
K800499PEDIATRIC ANESTHESIA BREATHING CIRCUITSAirlife, Inc.1980-03-25210
K792364TEE ADAPTERAirlife, Inc.1979-12-04110
K792217AIR INCENTIVE SPIROMETER, W/NEBULIZERAirlife, Inc.1979-11-27220
K792218MISTY BEBULIZERAirlife, Inc.1979-11-27220
K792030TWO-PIECE I.P.P.B. MANIFOLD-WITH RIGHTAirlife, Inc.1979-10-30210
K792047CIRCUIT, BREATHING (W/ CONNECTOR, ADAPT,Airlife, Inc.1979-10-30180
K791761CIRCUIT, BREATHING W/WO NEBULIZERAirlife, Inc.1979-10-26510
K791856Y & ELBOW W/WO PORTSAirlife, Inc.1979-09-2670
K791821CORRUGATED FLEXIBLE POLYETHYLENE & EVAAirlife, Inc.1979-09-26120
K791819AIR INCENTIVE SPIROMETERAirlife, Inc.1979-09-26120
K791820I.P.P.B. MANIFOLDS & NEB. SING. & DBLAirlife, Inc.1979-09-26120
K791443TWO-PIECE IPPB MANIFOLD FOR SUPPLY LINEAirlife, Inc.1979-08-28320
K791445TWO-PIECE IPPB MANIFOLD MACHINESAirlife, Inc.1979-08-28320
K791444UNIVERSAL TWO-PIECE MACHINESAirlife, Inc.1979-08-28320
K790892MISTY NEBULIZERAirlife, Inc.1979-07-24780
K790888TRACH T WITH ONE-WAY VALVESAirlife, Inc.1979-06-27510
K790890TEMPO2-I DISPOSABLE THERMOMETERSAirlife, Inc.1979-06-27510
K790891TEMPO2-II DISPOSABLE THERMOMETERSAirlife, Inc.1979-06-27510
K791042I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSALAirlife, Inc.1979-06-1380
K790887TEE ADAPTERAirlife, Inc.1979-06-05290

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda