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

Hospitak, Inc. — Predicate Candidate Screening

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

28 daysmedian FDA review time

105 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K955483	TRACH MASK MODEL (245, 246)	Hospitak, Inc.	1996-02-28	89	0
K954787	ILLUMINATOR	Hospitak, Inc.	1996-01-31	105	0
K953620	WARM N WET HMEF W/LUER ADAPTER	Hospitak, Inc.	1995-08-25	22	0
K953619	WARM N WET HME W/LUER ADAPTER	Hospitak, Inc.	1995-08-25	22	0
K915750	DISPOSABLE BACTERIAL BREATHNG FILTER	Hospitak, Inc.	1994-11-30	1077	0
K920842	AEROSOL DELIVERY SYSTEMS	Hospitak, Inc.	1992-05-15	81	0
K915228	DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL	Hospitak, Inc.	1992-02-11	83	0
K873286	DISPOSABLE, MANUAL PULMONARY RESUSCITATOR	Hospitak, Inc.	1987-10-26	70	23
K853600	INFLATABLE AIR SPLINTS	Hospitak, Inc.	1985-09-19	23	0
K844328	OXYGEN CONCENTRATOR	Hospitak, Inc.	1984-12-04	27	0
K843212	LOW PRESSURE ALARM FOR OXYGEN CYLINDER	Hospitak, Inc.	1984-09-19	35	0
K840817	DISPOSABLE, HYPERBARIC OXYGEN CHAMBER	Hospitak, Inc.	1984-04-25	61	0
K840276	DISPOSABLE, PRESSURE RELIEF VALVE	Hospitak, Inc.	1984-04-23	91	0
K841240	DISPOSABLE ANESTHESIA MASK	Hospitak, Inc.	1984-04-05	13	0
K831825	DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM	Hospitak, Inc.	1983-10-27	142	0
K831270	DISPOS. MEDICATION NEBULIZER	Hospitak, Inc.	1983-06-08	50	0
K802062	SOF-TOUCH NASAL CANNULA CAT.#304 & 305	Hospitak, Inc.	1980-09-09	13	0
K792426	DISPOSABLE TEMPERATURE PROBE	Hospitak, Inc.	1980-01-16	49	0
K792598	DISPOSABLE INCENTIVE SPIROMETER	Hospitak, Inc.	1980-01-04	17	0
K791539	DISPOSABLE 22MM ADAPTOR	Hospitak, Inc.	1979-09-07	28	0
K791537	DISPOSABLE MOUTHPIECE	Hospitak, Inc.	1979-09-07	28	0
K791536	DISPOSABLE MEDICATION NEBULIZER	Hospitak, Inc.	1979-09-07	28	0
K791538	DISPOSABLE AEROSOL T	Hospitak, Inc.	1979-09-07	28	0
K791469	MANIFOLD/NEBULIZER BREATHING PRODUCTS	Hospitak, Inc.	1979-08-28	22	0
K781908	BREATHING CIRCUIT PRODUCTS, ANESTHESIA	Hospitak, Inc.	1978-11-27	13	0
K781055	FACE TENTS	Hospitak, Inc.	1978-07-17	24	0
K780626	VENTURI OXYGEN MASK	Hospitak, Inc.	1978-05-26	42	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