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

Dms Laboratories — Predicate Candidate Screening

23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

27 daysmedian FDA review time

44 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days
K831186	RAPID NFT	Dms Laboratories	1983-05-09	27
K831187	TRP	Dms Laboratories	1983-05-09	27
K830437	CHS	Dms Laboratories	1983-03-17	36
K823102	AGAR P	Dms Laboratories	1982-12-03	44
K821038	FAST VIOLET B	Dms Laboratories	1982-05-27	44
K813612	RAPID ZYME	Dms Laboratories	1982-02-22	55
K813613	RAPID CH	Dms Laboratories	1982-02-22	55
K820209	ZYME B	Dms Laboratories	1982-02-12	17
K820210	IND	Dms Laboratories	1982-02-12	17
K820211	NINHYDRIN	Dms Laboratories	1982-02-12	17
K820213	SALINE SOLUTION	Dms Laboratories	1982-02-12	17
K820212	OXI	Dms Laboratories	1982-02-12	17
K820205	VP 2	Dms Laboratories	1982-02-05	10
K820206	NIT 1	Dms Laboratories	1982-02-05	10
K820208	ZYME A	Dms Laboratories	1982-02-05	10
K820214	SUCROSE	Dms Laboratories	1982-02-05	10
K820204	VP I	Dms Laboratories	1982-02-05	10
K820207	NIT 2	Dms Laboratories	1982-02-05	10
K813611	CHE	Dms Laboratories	1982-02-04	37
K813610	RAPID STREP	Dms Laboratories	1982-02-04	37
K813609	RAPID E	Dms Laboratories	1982-02-04	37
K813614	STAPH TRAC	Dms Laboratories	1982-02-04	37
K813615	CHL	Dms Laboratories	1982-02-04	37

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