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

JEB — Predicate Candidate Screening

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

31 daysmedian FDA review time

68 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K905816	ORTHOVISION TABLE	American Sterilizer Co.	1991-03-06	68
K900405	SCHOLTEN FRAME	Scholten Surgical Instruments, Inc.	1990-03-01	31
K891917	ORTHO-J, INC. BEK-JS-004	Ortho-J, Inc.	1989-05-26	60
K891387	WILLIAMS BELT & BOOT	Arthro-Medic, Inc.	1989-05-23	70
K881101	K ORTHOPEDIC TABLE	Instrumentation Specialties, Inc.	1988-04-06	22
K880263	OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION	Orthopedic Systems, Inc.	1988-03-15	53
K873274	PLASTER TABLE 1418	Stierlen-Maquet AG	1987-09-17	31
K873276	EXTENSION DEVICE 1416	Stierlen-Maquet AG	1987-09-17	31
K873275	EXTENSION TABLE 1417	Stierlen-Maquet AG	1987-09-17	31
K873273	ORTHOPAEDIC TABLE 1420	Stierlen-Maquet AG	1987-09-17	31
K781082	CAST BLOCK	Orthopedic Equipment Co., Inc.	1978-07-07	8
K772321	ARTHROSTRESS	Mtd, Inc.	1978-01-03	15
K771020	SPINAL SURGERY FRAME	Orthopedic Systems, Inc.	1977-06-17	11

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