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

Carwild Corp. — Predicate Candidate Screening

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

213 daysmedian FDA review time

378 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K913303	LAP SPONGES, MODIFIED	Carwild Corp.	1992-08-06	378	0
K913302	DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED	Carwild Corp.	1992-07-23	364	0
K833688	SUTURE REMOVAL KITS STERILE	Carwild Corp.	1984-05-31	213	0
K791872	LAP SPONGES	Carwild Corp.	1979-11-13	53	0
K791871	NEUROLOGICAL SPONGES (PATTIES)	Carwild Corp.	1979-11-05	45	2
K791870	DISPOSABLE SPECIALITY SPONGES	Carwild Corp.	1979-11-05	45	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