Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KQZ — Predicate Candidate Screening

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

27 daysmedian FDA review time

53 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K884132	TECNOL BUCKS TRACTION W/HEEL PROTECTOR	Technol, Inc.	1988-10-11	11
K882640	TECNOL SECURE-ALL PELVIC TRACTION BELT	Tecnol New Jersey Wound Care, Inc.	1988-07-27	30
K871900	OVER DRAPE LEG HOLDER	Avec Scientific Design Corp.	1987-06-16	32
K871296	T.E.D.(TM) TRACTION DEVICE	The Kendal Co.	1987-04-15	15
K854270	MURPHY ADJUSTABLE SPLINT	Comfortex, Inc.	1985-12-09	47
K831002	TPG 1000	Physical Diagnostics, Inc.	1983-06-24	87
K823660	UNIVERSAL BUCKS TRACTION	Warm & Form, Orthopedic Materials	1982-12-30	24
K823163	UNIVERSAL BUCKS TRACTION	Warm & Form, Orthopedic Materials	1982-11-10	16
K821252	HOFFMAN UNIVERSAL FOOT SUPPORT	Howmedica Corp.	1982-06-22	53
K802869	BACKTRAC 90-90 TRACTION	Backtrac	1980-12-11	27
K781754	SPLINT, HOAKE INFLATABLE AIR	Depuy, Inc.	1978-11-08	22

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