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

Hood Laboratories — Predicate Candidate Screening

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

84 daysmedian FDA review time

187 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K921452	ACOUSTIC RHINOMETER	Hood Laboratories	1993-07-08	469	0
K920994	HOOD NASAL SEPTAL BUTTON	Hood Laboratories	1992-05-15	74	0
K905703	KRUPIN EYE VALVE WITH DISK	Hood Laboratories	1991-03-15	85	4
K904821	ELIACHAR MODIFIED ESOPHAGEAL STENT	Hood Laboratories	1991-01-14	82	0
K897049	GIBSON ENDOLYMPHATIC SHUNT	Hood Laboratories	1990-03-16	88	0
K897059	HOOD SPEAKING VALVE	Hood Laboratories	1990-03-12	84	0
K893866	HOOD PEDIATRIC TRACHEOSTOMY TUBE	Hood Laboratories	1989-08-07	73	1
K884810	SILICONE LARYNGEAL STENT	Hood Laboratories	1989-05-10	174	0
K890599	HOOD NASAL SPLINT	Hood Laboratories	1989-03-17	39	0
K885125	KRUPIN EYE VALVE W/SCLERAL BUCKLE	Hood Laboratories	1989-01-24	43	0
K882430	HOOD TRACHEAL STOMA BUTTON	Hood Laboratories	1988-06-28	14	0
K873742	HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES	Hood Laboratories	1987-10-01	15	0
K871244	HOOD ESOPHAGEAL PROSTHESIS	Hood Laboratories	1987-04-13	17	0
K864533	HOOD BIFURCATED T-TUBE	Hood Laboratories	1987-03-09	111	0
K854112	FLEXIBLE GRASPING FORCEPS	Hood Laboratories	1986-03-12	155	0
K853726	LARYNGEAL	Hood Laboratories	1986-03-12	187	0
K853511	THE HOOD LIFE SAVER	Hood Laboratories	1985-12-19	120	0
K853940	THE GRONINGEN VOICE PROSTHESIS	Hood Laboratories	1985-12-13	80	0
K853419	CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE	Hood Laboratories	1985-12-06	114	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