Polymed Therapeutics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Polymed Therapeutics, Inc.” (first 2012, latest 2014), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 174 days. 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 | 1 | 361 |
| 2013 | 2 | 294 |
| 2014 | 2 | 74 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
Review panels
Most recent Polymed Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | LDJ | 2014-09-25 | 28 |
| K132834 | FASTEP S10 HCG SERUM/URINE COMBO TEST | JHI | 2014-01-09 | 121 |
| K121065 | POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE | DKZ | 2013-05-24 | 413 |
| K122907 | FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER | LCX | 2013-03-14 | 174 |
| K112101 | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS | JHI | 2012-07-17 | 361 |
Recalls
openFDA lists no recalls under a recalling firm named Polymed Therapeutics, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Polymed Laboratories (2 510(k)s)
- Polymed (Xiamen) Plastic Industrial Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Polymed Therapeutics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Polymed Therapeutics, Inc.” (first 2012, latest 2014), across 4 product codes in 2 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 Polymed Therapeutics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Polymed Therapeutics, Inc. is 174 days.
Which FDA product codes appear under Polymed Therapeutics, Inc.?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 2); DKZ (Enzyme Immunoassay, Amphetamine, 1); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 1).
Next steps
- See all 5 Polymed Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Polymed Therapeutics, 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.