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

W.H.P.M., Inc. — Predicate Candidate Screening

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

97 daysmedian FDA review time

301 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K200754	Hemosure Accu-Reader A100	W.H.P.M., Inc.	2022-06-02	801
K210327	First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug T	W.H.P.M., Inc.	2021-08-12	189
K171695	First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug C	W.H.P.M., Inc.	2018-02-05	243
K160793	First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortript	W.H.P.M., Inc.	2016-08-17	147
K152551	First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign	W.H.P.M., Inc.	2015-11-09	62
K151441	First Sign Drug of Abuse Dip Card Test, First Sign Drug of A	W.H.P.M., Inc.	2015-06-29	31
K150162	First Sign Drug of Abuse Dip Card Test, First Sign Drug of A	W.H.P.M., Inc.	2015-02-26	31
K142353	First Sign Drug of Abuse Dip Card Test/First Sign Drug of Ab	W.H.P.M., Inc.	2014-10-07	47
K052197	FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST	W.H.P.M., Inc.	2006-06-09	301
K051841	WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST	W.H.P.M., Inc.	2005-08-22	46
K041202	HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST	W.H.P.M., Inc.	2004-08-12	97
K041273	ONE-STEP PREGNANCY TEST	W.H.P.M., Inc.	2004-05-20	8
K032575	FIRST SIGN DRUG OF ABUSE SCREENING TEST	W.H.P.M., Inc.	2004-05-19	273
K012284	WH ACCU TEST PREGNANCY TEST	W.H.P.M., Inc.	2001-08-28	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