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

KMG · Predicate Candidate Screening

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

35 daysmedian FDA review time

186 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K012029	REMEDY MODEL 2Z12	Apollo Corp.	2001-12-31	186
K832288	HEMOGLOBINOMETER	Mallinckrodt Critical Care	1983-09-01	50
K831253	LANCER HEMOGLOBIN ANALYZER REAGENTS	Sherwood Medical Co.	1983-05-09	21
K813049	AQUANOMICS, #HHU100	Cooper-Hewitt Electric Co.	1981-12-02	35
K813045	AQUANOMICS, #SP36SF	Cooper-Hewitt Electric Co.	1981-12-02	35
K813048	AQUANOMICS, #MP2SF	Cooper-Hewitt Electric Co.	1981-12-02	35
K813050	AQUANOMICS, #MP4SF	Cooper-Hewitt Electric Co.	1981-12-02	35
K813047	AQUANOMICS, MINI 60L	Cooper-Hewitt Electric Co.	1981-12-02	35
K813046	AQUANOMICS, #HHU60	Cooper-Hewitt Electric Co.	1981-12-02	35

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