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

Grand Medical Products · Predicate Candidate Screening

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

72 daysmedian FDA review time

74 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K963724	GAUZE SPONGE, NON X-RAY DETECTABLE	Grand Medical Products	1996-11-29	74
K963722	IV START KIT	Grand Medical Products	1996-11-27	72
K963715	DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY	Grand Medical Products	1996-11-27	72
K963714	GRAND MEDICAL SUTURE REMOVAL KIT	Grand Medical Products	1996-11-27	72
K963721	SKIN SCRUB TRAY	Grand Medical Products	1996-11-27	72
K963719	CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE T	Grand Medical Products	1996-11-27	72
K963720	TRACHEOSTOMY KIT	Grand Medical Products	1996-11-27	72
K963723	LACERATION TRAY	Grand Medical Products	1996-11-27	72

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