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

ILZ — Predicate Candidate Screening

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

43 daysmedian FDA review time

96 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K921711	FLEXION DISTRATION SUPPORT	Altoona Medical Supply	1992-07-13	96
K895382	VIBRA-TRAC TRACTION TABLE	Vibra-Trac Industries	1989-10-16	47
K884340	AMX-110, AMX-II AND AMX-III	Dyna-Med	1989-01-24	102
K852398	VECTOR BAR SUSPENSION/TRACTION UNIT	Powlan Manufacturing Co.	1985-08-12	67
K844490	TRACTION ACCESSORIES	Jerome Medical	1985-02-21	93
K831135	SAUNDERS #7080 CERVICAL TRACTION SYS	Chattanooga Group, Inc.	1983-06-24	78
K830245	HEAD HALTER	Warm & Form, Orthopedic Materials	1983-03-09	43
K823659	PELVIC TRACTION BELT	Warm & Form, Orthopedic Materials	1982-12-30	24
K823166	PELVIC TRACTION BELT	Warm & Form, Orthopedic Materials	1982-11-10	16
K820663	BOGER AUTO-TRACTION DEVICE	D.C. Medical Device, Inc.	1982-05-03	54
K791808	CERVI-TRAC	Dr. K.G. Rude	1979-10-01	20
K780227	BANDAGE SPREADER BLOCK	Biomet, Inc.	1978-03-15	34
K780234	TRACTION BELT, PELVIC	Biomet, Inc.	1978-02-23	14
K780226	SPREADER BARS	Biomet, Inc.	1978-02-17	8
K770607	TRACTION HARNESS	Will Ross Co.	1977-04-08	8

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