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

IQI — Predicate Candidate Screening

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

17 daysmedian FDA review time

43 days90th percentile

52clearances measured

K-number	Device	Applicant	Decided	Review days
K143458	Neurosplint	Neurospectrum, LLC	2015-08-13	252
K052771	SENSOR WALK	Otto Bock Healthcare LP	2006-05-03	215
K031576	SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1	Surgitech, Inc.	2003-07-31	72
K926391	ACCUFLEX DYNAMIC ELBOW ORTHOSIS	Regulatory & Marketing Services, Inc.	1993-07-22	213
K910974	MCCONNELL SHOULDER BRACE	Mcconnell Orthopedic	1991-03-21	14
K874502	GAIT-AID ORTHOPEDIC INSOLE	Gait-Aid, Inc.	1987-11-30	28
K831542	ADJUSTABLE POLYCENTRIC ELBOW HINGE	Fred Sammons, Inc.	1983-06-24	43
K831615	DROP FOOT BRACE	Edward Dilauro, Jr.	1983-06-15	27
K823812	VARIOUS SUPPORTS AND SPLINTS	Danek Medical, Inc.	1983-01-14	28
K823113	BRACE-UP ALL PURPOSE WRIST BAND	Arco Matic, Inc.	1982-11-16	26
K823160	ROTATION BOOT	Warm & Form, Orthopedic Materials	1982-11-10	16
K823114	BRACE-UP STOCKING KNEE BRACE	Arco Matic, Inc.	1982-11-05	15
K822767	UNIVERSAL DYNASPLINT	Dynasplint Systems, Inc.	1982-10-06	22
K822022	SPORT SUPPORTS	Ginny, Inc.	1982-07-26	17
K821704	FRACTURE BRACING	Hosmer Dorrance Corp.	1982-06-24	22
K821641	OBTHOSES	Fred Sammons, Inc.	1982-06-11	8
K821640	ORTHOTIC FABRICATION ACCESSORIES	Fred Sammons, Inc.	1982-06-11	8
K821582	WARM'N FORM SPORTS SUPPORTS	Jerome Medical	1982-06-10	13
K820469	WARM & FORM KNEE SUPPORTS	Thermo-Mold Medical Products, Inc.	1982-03-08	14
K811704	MULTITUBULAR AIR SPLINT KIT	Roger Cestac & Assoc.	1981-07-01	15
K811690	ANKLE-FOOT CAST/SPLINT	Surgical Appliance Industries, Inc.	1981-06-25	10
K811490	FOREARM & KNEE STRAPS	Fred Sammons, Inc.	1981-06-12	17
K811456	ORTHO-FRAC KIT	Orthomedics	1981-06-12	21
K811343	HUMERAL FRACTURE CAST BRACE	Deseret Medical, Inc.	1981-05-28	16
K811035	PRO COMFORT TENNIS ELBOW SUPPORT/WRIST	Scholl, Inc.	1981-04-29	13
K810443	LIMB ORTHOSIS	Fred Sammons, Inc.	1981-03-04	13
K810288	AIRCAST TENNIS ARM BAND	Aircast, Inc.	1981-02-12	10
K802910	PLASTIC FRACTURE CAST BRACE KNEE JOINT	Orthomedics	1980-12-22	35
K802908	ULNAR FRACTURE BRACE	Orthomedics	1980-12-17	30
K802909	HUMERAL FRACTURE BRACE	Orthomedics	1980-12-17	30
K802871	TIBIAL FRACTURE BRACE	Orthomedics	1980-12-11	27
K802104	C-SPLINT	Cutter Laboratories, Inc.	1980-09-16	13
K801788	HUMEROUS FRACTURE BRACE, ULNA FRACTURE	Hosmer Dorrance Corp.	1980-08-07	9
K801708	BK-1520-01 ECONOMY WRIST SUPPORT, CHILD	Fred Sammons, Inc.	1980-08-07	14
K801701	BAUER & BLACK RIGID WRIST BRACE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1980-08-07	14
K800715	OHC DYNAMIC CLUB FOOT BRACE	Ipos Luneburg	1980-05-02	32
K791565	PARAPODIUM	Physico-Medical Systems Corp.	1979-08-28	13
K791248	SECUTE ELBOW BAND	Conphar, Inc.	1979-07-24	18
K791266	SECUTEX KNEE BAND	Conphar, Inc.	1979-07-24	18
K791267	SECUTEX ANKLE BAND	Conphar, Inc.	1979-07-24	18
K791249	SECUTEX WRIST BRACE	Conphar, Inc.	1979-07-24	18
K791057	CAST BRACE COMPONENTS	3M Company	1979-06-20	12
K781206	FOOT POSITIONER	Fred Sammons, Inc.	1978-07-31	17
K780979	AIRSTIRRUP PNEUMATIC ANKLE BRACE	Aircast, Inc.	1978-06-30	21
K780225	ORTHOSISES DEVICES	Biomet, Inc.	1978-02-24	15
K780053	BRACE, TENNIS ELBOW	Bd Becton Dickinson Vacutainer Systems Preanalytic	1978-01-17	8
K771676	FOOT DROP BOOT	Medical Restraints, Inc.	1977-09-20	18
K770612	SPLINT, BOHLER	Will Ross Co.	1977-04-08	8
K770167	KNEE SEPARATOR	Bel-Art Products	1977-01-28	3
K761312	ORTHOTIC BRACING	Hosmer Dorrance Corp.	1977-01-10	18

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