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

Grace Medical, Inc. — Predicate Candidate Screening

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

72 daysmedian FDA review time

136 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K232059	Tympanostomy Tubes	Grace Medical, Inc.	2023-11-24	136	0
K161376	DragonFly Surgical Drill System	Grace Medical, Inc.	2016-08-25	99	0
K091187	GRACE DYNAMIC TORP	Grace Medical, Inc.	2009-09-14	144	0
K080070	K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTH	Grace Medical, Inc.	2008-04-17	98	0
K063374	NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PIST	Grace Medical, Inc.	2006-12-06	28	0
K062672	GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES	Grace Medical, Inc.	2006-10-24	46	0
K062385	BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES	Grace Medical, Inc.	2006-09-27	43	0
K061853	GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OS	Grace Medical, Inc.	2006-08-18	49	0
K060518	PARTIAL OSSICULAR REPLACEMENT PROSTHESES	Grace Medical, Inc.	2006-06-28	121	1
K991394	STAPES PROSTHESES	Grace Medical, Inc.	1999-05-18	27	0
K981575	TYMPANOSTOMY TUBE	Grace Medical, Inc.	1998-07-15	72	0
K972815	PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT	Grace Medical, Inc.	1997-10-08	72	0
K963752	PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS	Grace Medical, Inc.	1996-10-10	22	0
K943325	TYMPANOSTOMY TUBE	Grace Medical, Inc.	1994-10-11	92	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