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

HST — Predicate Candidate Screening

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

23 daysmedian FDA review time

93 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days
K162702	Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter	Stl International, Inc.	2016-12-30	93
K110858	LO-BAK TRAX	Roland F Berthiaume, DC	2011-08-02	127
K984190	BACK-ON-TRAC, MODEL 101BOT	Back-On-Track, Inc.	1999-03-15	112
K872121	K AND D HOME TRACT	Joseph A. Kott, M.D.	1987-08-12	77
K870212	ARTHROSCOPIC SHOULDER HOLDER	Dyonics, Inc.	1987-02-20	31
K870125	EXTREMITY ELEVATOR	Orthopedic Systems, Inc.	1987-02-04	23
K870102	TUPPER TROLLEY	Orthopedic Systems, Inc.	1987-02-03	25
K864765	MODEL 668, TRACTION SPLINT, ADULT	Ferno-Washington, Inc.	1986-12-17	12
K862874	THE TOWERED 90/90 UNIT	Lossing Orthopedic, Inc.	1986-08-07	8
K855179	TRANSFER-TRAX (TM) SPLINT TRACTION	Comfortex, Inc.	1986-01-21	26
K860037	SUSPENDER ORTHOPEDIC SUSPENSION DEVICE	Comfortex, Inc.	1986-01-21	15
K844239	NEC-KRADLE BY VENCOR	Vencor	1984-11-19	18
K841368	HYPERBARIC OXYGEN GURNEY-	Orthopedic Systems, Inc.	1984-05-16	43
K841388	ACUFEX SHOULDER HOLDER	Acufex Microsurgical, Inc.	1984-05-16	43
K831888	COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG	Portable Travtion Device Co.	1983-07-12	29
K830244	TRACTION ACCESSORIES	Warm & Form, Orthopedic Materials	1983-03-09	43
K823813	TRACTION ACCESSORIES	Danek Medical, Inc.	1983-01-14	28
K823395	TRACTION-STEEL FRAMING SYSTEM	Orthopedic Systems, Inc.	1982-12-03	21
K823372	OCTAGONAL ALUMINUM FRAMING SYSTEM	Orthopedic Systems, Inc.	1982-12-03	21
K823392	FOREARM REDUCTION UNIT	Orthopedic Systems, Inc.	1982-11-29	17
K822993	SENATEK	American Health Tech., Inc.	1982-10-26	14
K821522	CERVITRAC TRACTION FRAME & CORD	George W. Cottrell	1982-06-21	35
K820612	TENSOPLAST SKIN TRACTION KIT	Smith & Nephew, Inc.	1982-03-31	23
K813017	NECKTRAC	Lossing Orthopedic, Inc.	1981-11-25	29
K813016	ZEE TRACTION SPLINT	Zee Medical Products Co., Inc.	1981-11-24	28
K812779	EXTENSIONS-LUSATZTISCH	The Telos Co.	1981-10-26	21
K803021	UPPER EXTREMITY TRACTION DEVICE	Orthopedic Systems, Inc.	1980-12-12	16
K802555	COTTRELL 90/90 BACKTRAC	Lossing Orthopedic, Inc.	1980-10-31	15
K802072	PROT-A-TRAC	Robert I. Branick, M.D.	1980-09-26	30
K792248	TAYLOR TRACTION CORD	Taylor Medical Equipment	1979-11-30	23
K791919	BAC JAC	Haggin Industries, Inc.	1979-10-04	9
K791396	MEDI-TRAK PORTABLE TRACTION DEVICE	Medicorp, Inc.	1979-08-16	37
K790729	OCTAGONAL ALUMINUM FRAMING SYSTEM	Orthopedic Systems, Inc.	1979-05-01	19
K771988	VERTETRAC	Ballert Orthopedic Corp.	1979-02-01	470
K781647	BACK TRAC	Tech Engineering, Inc.	1978-10-17	20
K780233	TRACTION WEIGHT BAGS	Biomet, Inc.	1978-02-23	14
K780228	TRACTION UNITS	Biomet, Inc.	1978-02-23	14
K770080	BAKER MOBILE TRACTION	Orthopedic Equipment Co., Inc.	1977-01-25	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