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

CIE — Predicate Candidate Screening

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

45 daysmedian FDA review time

130 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K904761	P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT	Instrumentation Laboratory CO	1990-11-20	32
K880967	MICRO CO2 APPARATUS	Hf Scientific, Inc.	1988-04-28	51
K864313	CO2 REAGENT SET	Hf Scientific, Inc.	1987-03-13	130
K832071	TOTAL CO2 REAGENT SET	American Research Products Co.	1983-08-11	45
K820091	AIRMED SMOKE EVACUATION & FILTER	James L. Geraci & Associates, Inc.	1982-02-24	42
K800524	SERALYZER REFLECTANCE PHOTOMETER/CALIB.	Miles Laboratories, Inc.	1980-04-02	27
K771610	CARBON DIOXIDE ANALYZER	Corning Medical & Scientific	1977-10-07	46

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