W.H.P.M., Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “W.H.P.M., Inc.” (first 2001, latest 2022), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 80 days. Since 2017 the median was 243 days, against 120 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 47 |
| 2015 | 3 | 31 |
| 2016 | 1 | 147 |
| 2017 | 0 | — |
| 2018 | 1 | 243 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 189 |
| 2022 | 1 | 801 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name W.H.P.M., Inc. took a median 243 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DJR | Enzyme Immunoassay, Methadone | 3 | 3 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| KHE | Reagent, Occult Blood | 1 | 1 |
| LAF | Gas Chromatography, Methamphetamine | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
| NFT | Test, Amphetamine, Over The Counter | 1 | 1 |
| OOX | Automated Occult Blood Analyzer | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Toxicology (9)
- Clinical Chemistry (3)
- Hematology (2)
Most recent W.H.P.M., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200754 | Hemosure Accu-Reader A100 | OOX | 2022-06-02 | 801 |
| K210327 | First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup | QBF | 2021-08-12 | 189 |
| K171695 | First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana | NFT | 2018-02-05 | 243 |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) | DJR | 2016-08-17 | 147 |
| K152551 | First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test. | DJG | 2015-11-09 | 62 |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | DJR | 2015-06-29 | 31 |
| K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | LAF | 2015-02-26 | 31 |
| K142353 | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test | DIO | 2014-10-07 | 47 |
| K052197 | FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST | DJR | 2006-06-09 | 301 |
| K051841 | WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST | JHI | 2005-08-22 | 46 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named W.H.P.M., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under W.H.P.M., Inc.?
FDA lists 14 510(k) clearances under the applicant name “W.H.P.M., Inc.” (first 2001, latest 2022), across 11 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by W.H.P.M., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name W.H.P.M., Inc. is 80 days. Since 2017: 243 days, versus 120 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under W.H.P.M., Inc.?
The most frequent FDA product codes under this applicant name are DJR (Enzyme Immunoassay, Methadone, 3); JHI (Visual, Pregnancy Hcg, Prescription Use, 2); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 1).
Next steps
- See all 14 W.H.P.M., Inc. clearances with predicates and recalls
- Run predicate analysis for product code DJR, W.H.P.M., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.