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

EFN — Predicate Candidate Screening

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

32 daysmedian FDA review time

143 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K872810	STRUNG DENTAL ROLLS	American Silk Sutures, Inc.	1987-12-04	143	0
K871464	MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER	Medgroup Enterprises, Inc.	1987-04-30	16	0
K863764	COTTON ROLLS, NON-STERILE	The Medical Group, Inc.	1986-10-27	32	2
K861338	DENTAL COTTON ROLLS, STERILE AND NON-STERILE	Intl. Verbandstoff-Fabrik Schaffhau	1986-08-06	121	0
K861727	COTTON FILLED GAUZE SPONGES 2 X 2	Cross Country Paper Products Corp.	1986-07-10	65	0
K843539	TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-	Molnlycke A/S Hospital Products	1985-05-23	258	0
K841327	DENTAL COTTON ROLLS	Intl. Verbandstoff-Fabrik Schaffhau	1984-07-03	92	0
K834056	SCHEIN COTTON ROLLS, NON-STERILE	Henry Schein, Inc.	1984-02-03	72	0
K830175	STERILE COTTON ROLLS #3, 1 1/2	Veratex Corp.	1983-02-18	31	0
K812709	STERILE DENTAL ROLL	Medspec Corp.	1981-10-23	29	0
K810830	HOYT COTTON ROLLS	Hoyt Laboratories	1981-04-14	20	0
K802429	COTTON ROLLS	Worldwide Surgical Gauze	1980-10-23	20	0
K792391	COTTON ROLL COMPRESSION CAPS	Parker Laboratories, Inc.	1979-12-06	10	0
K770063	DISP. ABSORBENT COMPRESSED FIBRE WAFER	Lorvic Corp.	1977-01-14	3	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