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

KTZ · Predicate Candidate Screening

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

35 daysmedian FDA review time

120 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K921266	NK MEDICAL MICROMETER, MODEL MC001	Nk Biotechnical Engineering Co.	1992-07-14	120
K841687	SKYNDEX ELECTRONIC BODY FAT CALCULA	Caldwell, Justiss & Co., Inc.	1984-06-28	66
K831898	SCOLIMETER	Dr. Micheal A. Sabia	1983-07-19	35
K820659	A CALIPER	Twin City Surgical, Inc.	1982-03-19	9
K810116	ISOROBIC SKINFOLD CALIPER	Fitness Motivation Institute of America	1981-02-04	20
K800363	PARKE-DAVIS TOTAL KNEE PROSTHESIS	Warner-Lambert Co.	1980-03-10	19
K760521	TAPE MEASURE	Mcgaw Laboratories	1976-11-12	78

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