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

FSE — Predicate Candidate Screening

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

30 daysmedian FDA review time

76 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K860503	THE POREX RETRACTOR TABLE	Porex Medical	1986-03-13	30
K843801	MASON EQUIPMENT ORGANIZER & ASPEN	Aspen Laboratories, Inc.	1984-10-25	28
K840027	OPERATING ROOM STAND	Healthmate, Inc.	1984-02-04	30
K831042	CHEMONUCLEOLYSIS TABLE EXTENSION	Orthopedic Systems, Inc.	1983-05-16	46
K830339	IMSI/METRIPOND HAND OPERATING TABLE	Intl. Management Services, Inc.	1983-04-12	70
K822427	SELF-CONTAINED MOBILE OPHTHAL. OPER. .	Surgi-Quip Inc.U	1982-09-14	33
K821924	TABLE, OPERATING, FIELD 6530-00-709-8155	Emerson-Sack-Warner Corp.	1982-07-13	14
K801382	DISPOSABLE SURGICAL HEAD SUPPORT	Innovative Surgical Products, Inc.	1980-06-26	14
K782092	ARMBOARD CVER, DISPOSABLE	Anago, Inc.	1979-01-10	27
K780866	CHEST ROLLS HOLDER	Devon Industries, Inc.	1978-08-14	76
K780867	PAD HOLDER KIT	Devon Industries, Inc.	1978-08-14	76
K780868	CHEST ROLLS	Devon Industries, Inc.	1978-08-14	76
K760308	I.V. SUPPORT, TECNOL ARMBOARD	Tecnol New Jersey Wound Care, Inc.	1976-08-11	16

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