Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KEO — Predicate Candidate Screening

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

28 daysmedian FDA review time

36 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K893772	TISSUE EMBEDDING MEDIUM	Stephens Scientific	1989-06-22	31
K862223	MICRO THIN* PARAFFIN	Richard-Allan Medical Ind., Inc.	1986-06-17	6
K862141	HISTOLOGY PARAFFIN	Erie Scientific Co.	1986-06-13	9
K861270	BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED.	Surgipath Medical Industries, Inc.	1986-04-11	7
K842053	PARAPLAST EXTRA TISSUE EMBEDDING MED.	Sherwood Medical Co.	1984-06-26	35
K833071	TECHNICON PARACUT	Technicon Instruments Corp.	1983-10-14	36
K831580	PARAFFIN INFILTRATION MEDIUM	Surgipath Medical Industries, Inc.	1983-06-17	31
K812191	VASPAR SEALENT	American Scientific Products	1981-08-31	28
K810568	PARAFFIN EMBEDDING MEDIUM	Surgipath Medical Industries, Inc.	1981-03-17	14
K803241	HISTOLOGICAL EMBEDDING MEDIA	Miles Laboratories, Inc.	1981-01-28	36
K760602	SORVALL EMBEDDING MEDIUM	E.I. Dupont DE Nemours & Co., Inc.	1976-09-21	14

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