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

Ohio Medical Products — Predicate Candidate Screening

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

26 daysmedian FDA review time

76 days90th percentile

47clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K841733	OHIO WASTE GAS SCAVENGING RESERVOIR	Ohio Medical Products	1984-07-11	76	0
K842003	OHIO WASTE GAS SCAVENGING INTERFACE	Ohio Medical Products	1984-05-23	7	0
K840356	OHIO UNITROL II ANESTHESIA GAS MACHINE	Ohio Medical Products	1984-04-20	85	0
K841274	BAG-TO-VENTILATOR SELECTOR VALVE	Ohio Medical Products	1984-04-13	17	0
K840857	OHIO 3000 INFANT WARMER SYSTEM	Ohio Medical Products	1984-03-23	28	0
K840858	OHIO 3300 INFANT WARMER SYSTEM	Ohio Medical Products	1984-03-23	28	1
K840967	OHIO HEAT REFLECTING PATCH	Ohio Medical Products	1984-03-23	17	0
K840453	MEDISHIELD PVM RESPIROMETER	Ohio Medical Products	1984-03-02	30	0
K840452	PREMIUM DABM DISPOS. ANES. BREATH MASK	Ohio Medical Products	1984-02-17	16	0
K833335	MODULUS II ANESTHESIA GAS MACHINE	Ohio Medical Products	1983-11-14	48	0
K830488	VENTILATOR #1	Ohio Medical Products	1983-09-15	212	0
K830618	BREATHING FILTER	Ohio Medical Products	1983-04-08	39	0
K823922	COMPUTERIZED SPIROMETRY SYSTEM	Ohio Medical Products	1983-02-24	58	0
K823257	NON-REUSABLE UNIVERSAL NEBULIZER FILTE	Ohio Medical Products	1982-12-09	38	0
K822888	OHIO CPU-1 INTENSIVE CARE VENTILATOR	Ohio Medical Products	1982-11-16	49	0
K822055	CNIBP BLOOD PRESSURE MEASUREMENT SYS	Ohio Medical Products	1982-11-01	111	0
K822311	DISPOSABLE COLLECTION BOTTLE W/TUBING	Ohio Medical Products	1982-08-20	17	0
K821966	MODULUS VERNI-TROL ANESTHETIC VAPORIZER	Ohio Medical Products	1982-07-16	14	0
K821376	OHIO 7000 ELECTRONIC ANESTHESIA VENTIL.	Ohio Medical Products	1982-06-29	50	0
K821144	OHIO ABSORBER	Ohio Medical Products	1982-05-28	37	0
K810990	OHIO NONCONDUCTIVE RBS TYPE FACE MASK	Ohio Medical Products	1981-04-23	10	0
K810289	MODULUS VERNI-TROL ANESTHETIC VAPORIZER	Ohio Medical Products	1981-03-04	30	0
K810290	OHIO CAL-CHEK	Ohio Medical Products	1981-02-12	9	0
K802702	NEONATAL PHOTOTHERAPY UNIT	Ohio Medical Products	1980-12-10	37	0
K802639	OHIO IC INCUBATOR	Ohio Medical Products	1980-11-12	20	0
K802640	OHIO GC INCUBATOR	Ohio Medical Products	1980-11-12	20	0
K802365	OHIO RADIANT WARMER	Ohio Medical Products	1980-10-23	24	0
K802285	OHIO THORACIC SUCTION REGULATOR	Ohio Medical Products	1980-10-03	14	0
K801942	OHIO THORACIC COLLECTION UNIT	Ohio Medical Products	1980-09-16	34	0
K801169	OHIO FREE FLOW VACUUM REGULATOR	Ohio Medical Products	1980-07-28	74	0
K801641	OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT	Ohio Medical Products	1980-07-28	11	0
K800634	OHIO DISPOSABLE TRACHEAL TUBE	Ohio Medical Products	1980-04-02	12	0
K791530	OHIO MODULAR ANESTHESIA GAS MACHINE	Ohio Medical Products	1979-09-19	40	0
K781871	DIFFUSION OPTION, OMNI-LAB	Ohio Medical Products	1979-01-02	60	0
K780064	SPIROMETER, MONITORING W/ALARM	Ohio Medical Products	1978-01-31	19	0
K780086	INFUSION APPARATUS, POWERED	Ohio Medical Products	1978-01-30	17	0
K772065	CRITICAL CARE VENTILATOR 2	Ohio Medical Products	1977-11-28	26	0
K771479	NITROX 30 - ANESTHETIC GAS PROPORTIONER	Ohio Medical Products	1977-11-07	95	0
K770996	OXYGEN CANNULA	Ohio Medical Products	1977-06-29	28	0
K770995	AEROSOL MASK	Ohio Medical Products	1977-06-27	26	0
K770838	ANESTHESIA BREATHING CIRCUIT, DISPOSABLE	Ohio Medical Products	1977-05-23	14	0
K770828	NEBULIZER HEATER	Ohio Medical Products	1977-05-23	17	0
K760580	DRUG NEBULIZER	Ohio Medical Products	1976-09-21	18	0
K760088	ANALYZER, SENTORR BLOOD GAS	Ohio Medical Products	1976-08-06	46	0
K760230	VALVE, PEEP	Ohio Medical Products	1976-08-06	23	0
K760102	FLOWMETER, P.C., REDESIGNED VERSION	Ohio Medical Products	1976-07-16	23	0
K760101	OXYGEN & RESUSCITATION (HOPE II MODEL)	Ohio Medical Products	1976-07-15	22	0

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