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

CED — Predicate Candidate Screening

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

30 daysmedian FDA review time

102 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K894288	PHOSPHORUS TEST ITEM NUMBER 65416	Em Diagnostic Systems, Inc.	1989-08-31	69
K840151	EKTACHEM CLINICAL CHEM. SLIDES	Eastman Kodak Company	1984-03-22	69
K833710	BTC URINE LH ASSAY	Btc Diagnostics, Inc.	1984-01-30	102
K820832	PHOSPHORUS IL	American Monitor Corp.	1982-04-15	20
K812670	SANDARE FAST 340 PHOSPHORUS PROCEDURE	Sandare Chemical Co., Inc.	1981-10-02	11
K811864	SIGMA PROCEDURE 265-UV	Sigma Chemical Co.	1981-07-31	30
K811222	INORGANIC PHOSPHORUS REAGENTS	Connecticut Diagnostics, Ltd.	1981-05-21	17
K802420	CENTRIFICHEM INORGANIC PHOSPHORUS	Union Carbide Corp.	1980-10-31	25
K790662	CENTRIFICHEM INORGANIC PHOSPHORUS	Union Carbide Corp.	1979-05-15	39

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