510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Airlife, Inc.

Mchenry, IL, US

Airlife, Inc. appears in FDA device records in Mchenry, IL. FDA records list 76 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
76
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 76

FDA records hold 76 510(k) clearances for Airlife, Inc. between 1979 and 1984. The busiest year on record is 1979, with 45. The most recent is 1984, with 2.

Clearances by year, as a table
510(k) clearance decisions for Airlife, Inc., by decision year
YearClearances
197945
198010
198110
19822
19837
19842
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K834573AQUA TRAPBYHSubstantially Equivalent
K834570VOLUME VENTILATOR CIRCUIT W/WATER TRAPBZOSubstantially Equivalent
K834077SINGLE USE NEBULIZER-ADJUST-AIR ENTRAINCAFSubstantially Equivalent
K833196VOLUME VENTILATOR CIRCUIT-NEBULIZERCAISubstantially Equivalent
K833197TRACH SWIVE/CONNECTORBTRSubstantially Equivalent
K832725DUAL DIAL VENTURI STYLE MASKBYFSubstantially Equivalent
K831246WHISTLER IN-LINE PRESSURE RELEASE VALVECBPSubstantially Equivalent
K830895SINGLE USE NEBULIZER, ADJUST. AIR-CAFSubstantially Equivalent
K830896HUMIDIFIER, WITH OR WITHOUT ADAPTERKFZSubstantially Equivalent
K821129AIRLIFE NEBULIZER HEATERCAFSubstantially Equivalent
K821128DISPOSABLE THERMOPLASTIC RUBBER MOUTHBYPSubstantially Equivalent
K812067INSPIRATORY FORCE PRESSURE ADAPTORBZASubstantially Equivalent
K812066PERCENTO MASK, PEDIATRIC, UNDER-THE-CHINBYFSubstantially Equivalent
K811908IMV MANIFOLDSCBOSubstantially Equivalent
K811890DISPOSABLE TRACH T OXYGENATORBZASubstantially Equivalent
K811711PEDIATRIC OXYGEN MASKSBYGSubstantially Equivalent
K811708UNIVERSAL ADAPTER SYSTEM-U/ADAPITBZASubstantially Equivalent
K811161HUMIDIFIER W/ OR W/OUT ADAPTORKFZSubstantially Equivalent
K810947AIR ENTRAINMENT TRACH TBYFSubstantially Equivalent
K810946ADULT & PEDIATRIC TRACHEOSTOMY MASKSBYFSubstantially Equivalent
K802852HUMIDIFIERBTTSubstantially Equivalent
K802663BLOW-BY-SET-UP CONNECTOR-AIRWAYBZASubstantially Equivalent
K802477MISTY NEBULIZERCAFSubstantially Equivalent
K802323PEDIATRIC OXYGEN OR AEROSOL MASKS,BYGSubstantially Equivalent
K801875CIRCUITS, BREATHING W/CONNECTORS, ADAPTCAFSubstantially Equivalent
K801252NEBULIZER WITH AIR ENTERTAINER & ETC.BTTSubstantially Equivalent
K801191ANESTHESIA BREATHING CIRCUITSCAISubstantially Equivalent
K801190OXYGEN TUBING (CRUSH RESISTANT)/VINYL TPBYXSubstantially Equivalent
K800990TRACH MIST UNIT W/OR WITHOUT ELBOWBYHSubstantially Equivalent
K800499PEDIATRIC ANESTHESIA BREATHING CIRCUITSCAISubstantially Equivalent
K800498ADULT ANESTHESIA BREATHING CIRCUITS . .CAISubstantially Equivalent
K792364TEE ADAPTERCAFSubstantially Equivalent
K792218MISTY BEBULIZERCAFSubstantially Equivalent
K792217AIR INCENTIVE SPIROMETER, W/NEBULIZERBWFSubstantially Equivalent
K792047CIRCUIT, BREATHING (W/ CONNECTOR, ADAPT,BZOSubstantially Equivalent
K792030TWO-PIECE I.P.P.B. MANIFOLD-WITH RIGHTBZOSubstantially Equivalent
K791761CIRCUIT, BREATHING W/WO NEBULIZERBZOSubstantially Equivalent
K791856Y & ELBOW W/WO PORTSBZOSubstantially Equivalent
K791821CORRUGATED FLEXIBLE POLYETHYLENE & EVABYXSubstantially Equivalent
K791820I.P.P.B. MANIFOLDS & NEB. SING. & DBLCAFSubstantially Equivalent
K791819AIR INCENTIVE SPIROMETERBWFSubstantially Equivalent
K791445TWO-PIECE IPPB MANIFOLD MACHINESCAFSubstantially Equivalent
K791444UNIVERSAL TWO-PIECE MACHINESCAFSubstantially Equivalent
K791443TWO-PIECE IPPB MANIFOLD FOR SUPPLY LINECAFSubstantially Equivalent
K790892MISTY NEBULIZERCAFSubstantially Equivalent
K790891TEMPO2-II DISPOSABLE THERMOMETERSFLKSubstantially Equivalent
K790890TEMPO2-I DISPOSABLE THERMOMETERSFQZSubstantially Equivalent
K790888TRACH T WITH ONE-WAY VALVESBZASubstantially Equivalent
K791042I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSALCAFSubstantially Equivalent
K790887TEE ADAPTERBZASubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Airlife, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Airlife, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

Data as of , FDA export datePage updated Source: openFDA, public domain