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

KIZ — Predicate Candidate Screening

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

21 daysmedian FDA review time

106 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K890542	MULTIWELL CULTURE PLATE INSERTS	Bd Becton Dickinson Vacutainer Systems Preanalytic	1989-02-14	11
K873891	TISSUE CULTURE DISHES	Nunc, Inc.	1987-11-25	63
K871483	TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES	Isratech Marketing Corp.	1987-04-29	14
K854724	CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE	Lifetrac, Inc.	1985-12-13	21
K853634	CORNING CELL WELLS-MULTIPLE WELL PLATES	Corning Medical & Scientific	1985-09-16	17
K821687	REMOVAWELL TISSUE CULTURE PLATE W/LID	Dynatech Corp.	1982-06-24	16
K790958	120 WELL HISTO-PLATE	Dynatech Laboratories, Inc.	1979-06-28	37
K781792	PRESSURIZER, EXETER CEMENT	Howmedica Corp.	1979-02-08	106

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