510(k) Report

FDA applicant

W.H.P.M., Inc.

Irwindale, CA14 decisions2001–20221 recall

FDA records 14 decisions for W.H.P.M., Inc. (Irwindale, CA) from 2001 to 2022: 14 510(k) clearances. Most are in product codes DJR (Enzyme Immunoassay, Methadone) and JHI (Visual, Pregnancy Hcg, Prescription Use). Its devices cite 17 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical toxicology panel, where it files most

How often FDA has decided W.H.P.M., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2014: 12015: 32016: 12018: 12021: 12022: 1
2007high 3 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — W.H.P.M., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like W.H.P.M., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DJREnzyme Immunoassay, Methadone3decisions
  • JHIVisual, Pregnancy Hcg, Prescription Use2decisions
  • KHEReagent, Occult Blood1decision
  • DJGEnzyme Immunoassay, Opiates1decision
  • DKZEnzyme Immunoassay, Amphetamine1decision
  • NFTTest, Amphetamine, Over The Counter1decision

Also: DIO (1), QBF (1), LCX (1), OOX (1), LAF (1).

Whose devices does it build on?

Its devices cite 17 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K041202Hemosure One-Step Fecal Occult Blood TestW.H.P.M., Inc. · 20041cites it

What has FDA decided for it lately?

  • K200754Hemosure Accu-Reader A100W.H.P.M., Inc. · 2022
  • K210327First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip…W.H.P.M., Inc. · 2021
  • K171695First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test…W.H.P.M., Inc. · 2018
  • K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA…W.H.P.M., Inc. · 2016
  • K152551First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test…W.H.P.M., Inc. · 2015
  • K151441First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestW.H.P.M., Inc. · 2015
  • K150162First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestW.H.P.M., Inc. · 2015
  • K142353First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup TestW.H.P.M., Inc. · 2014

All 14 as W.H.P.M., Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K041202McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers…Feb 27, 2019Class III