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

JSN — Predicate Candidate Screening

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

27 daysmedian FDA review time

90 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K000718	CHROMOSTREAK	Novamed , Ltd.	2000-08-24	174
K962745	ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)	Prepared Media Laboratory, Inc.	1996-10-02	79
K961756	CYTOQUANT VIRAL TRANSPORT MEDIUM	Proteins Intl., Inc.	1996-05-17	11
K961755	CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM	Proteins Intl., Inc.	1996-05-17	11
K896296	INPOUCH-TV POUCH	Biomed Diagnostics, Inc.	1990-01-29	90
K881579	AMIES TRANSPORT MEDIUM W/O CHARCOAL	Acumedia Manufacturers, Inc.	1988-04-18	7
K860967	VIRTRAN VIRAL TRANSPORTER (MODIFIED)	Diagnon Corp.	1986-04-04	25
K841208	PROPAGATING TRANSPORT	Smith River Biologicals	1984-04-05	24
K833968	10B	Remel Co.	1983-12-30	44
K834065	A3B	Remel Co.	1983-12-27	32
K831186	RAPID NFT	Dms Laboratories	1983-05-09	27
K792201	STREP CULTURETTE	Marion Health & Safety, Inc.	1979-11-30	28
K781304	TRANSPORT MEDIA	Bd Becton Dickinson Vacutainer Systems Preanalytic	1978-08-14	18

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