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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Airco/Ohio Medical Products · Predicate Candidate Screening

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

37 daysmedian FDA review time
67 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K833459COAXIAL VOL. VENTILATOR CIRCUITAirco/Ohio Medical Products1984-01-10970
K833452OHIO GMS ABSORBERAirco/Ohio Medical Products1983-11-29670
K832418OHIO TEMPERATURE SIMULATORAirco/Ohio Medical Products1983-09-12520
K832565OHIO 5400 VOLUME MONITORAirco/Ohio Medical Products1983-09-01300
K832185OHIO MODEL 922 SPIROMETERAirco/Ohio Medical Products1983-08-12370
K830446OXYGEN MONITOR OHIO 5100Airco/Ohio Medical Products1983-03-24420
K822456OHIO V5A ANESTHESIA VENTILATORAirco/Ohio Medical Products1982-09-21360
K813476OHIO VOLUME INCENTIVE SPIROMETERAirco/Ohio Medical Products1981-12-31300
K812879OHIO NON-REUSABLE TRACHEAL TUBE MURPHYAirco/Ohio Medical Products1981-11-24410
K812880OHIO NON-REUSABLE TRACHEAL TUBE MAJILLAirco/Ohio Medical Products1981-11-24410
K811413DABC NONCONDUCTIVE PEDIAT. ANESTH. CIRAirco/Ohio Medical Products1981-06-02140
K810763OHIO DISPOSABLE TRACHEAL TUBEAirco/Ohio Medical Products1981-03-2740
K790809VS, ANESTHESIA VENTILATORAirco/Ohio Medical Products1979-05-0480

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