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

IPY — Predicate Candidate Screening

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

20 daysmedian FDA review time

28 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K823882	M-BRACE	Buckman Consultants	1983-01-17	21
K823823	LUMBOSACRAL SUPPORT	Danek Medical, Inc.	1983-01-14	28
K812422	CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS	Surgical Appliance Industries, Inc.	1981-09-14	21
K812099	CASH ORTHOSIS	David Hendricks, C.P.O.	1981-08-13	20
K811494	LUMBO-SACRAL FLEXION ORTHOSIS	Surgical Appliance Industries, Inc.	1981-06-16	20
K810554	LUMBAR FLEXION BRACE	Orthomedics	1981-03-13	11
K810556	SPINAL EXTENSION BRACE	Orthomedics	1981-03-13	11
K803033	CRUSADER HYPEREXTENSION BRACE	Orthomedics	1980-12-22	21
K801712	LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC	Fred Sammons, Inc.	1980-08-07	14
K792269	WRIGHT DOW CORNING SOFTGOODS W/DOW	Dow Corning Wright	1980-02-05	88
K791314	VERTEBRACE SPINAL SUPPORTS	Vertebrace, Inc.	1979-07-30	14

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