Polymedica Industries, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Polymedica Industries, Inc.” (first 1993, latest 1997), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 68 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| MGP | Dressing, Wound And Burn, Occlusive | 6 | 6 |
| FLL | Continuous Measurement Thermometer | 3 | 3 |
| FRO | Dressing, Wound, Drug | 2 | 2 |
| KMF | Bandage, Liquid | 2 | 2 |
| FLK | Thermometer, Clinical Mercury | 1 | 1 |
| LHD | Device, Fertility Diagnostic, Proceptive | 1 | 1 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 1 | 1 |
Review panels
Most recent Polymedica Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964398 | SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED | MGP | 1997-10-24 | 354 |
| K971045 | BASIS FLEXIBLE TIP DIGITAL THERMOMETER | FLL | 1997-05-02 | 42 |
| K964701 | MITRAFLEX PIGMENTED WOUND DRESSING | FRO | 1997-02-07 | 74 |
| K963623 | SPYROFLEX PIGMENTED WOUND DRESSING | MGP | 1996-10-25 | 44 |
| K962991 | BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER | FLL | 1996-09-12 | 42 |
| K955383 | SPYROCOLLOID WOUND DRESSING | MGP | 1995-12-13 | 19 |
| K953885 | SPYROFLEX SKIN PROTECTOR | MGP | 1995-11-29 | 104 |
| K952756 | MEDI-AID BASAL THERMOMETER | LHD | 1995-09-25 | 101 |
| K952159 | BASIS DIGITAL THERMOMETER | FLL | 1995-09-22 | 137 |
| K953618 | SPYROFLEX WOUND DRESSING | MGP | 1995-08-21 | 18 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Polymedica Industries, 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.
- Polymedica Healthcare, Inc. (1 510(k)s)
- Polymedica Pharmaceuticals, U.S.A., Inc.] (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Polymedica Industries, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Polymedica Industries, Inc.” (first 1993, latest 1997), across 7 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 Polymedica Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Polymedica Industries, Inc. is 68 days.
Which FDA product codes appear under Polymedica Industries, Inc.?
The most frequent FDA product codes under this applicant name are MGP (Dressing, Wound And Burn, Occlusive, 6); FLL (Continuous Measurement Thermometer, 3); FRO (Dressing, Wound, Drug, 2).
Next steps
- See all 16 Polymedica Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MGP, Polymedica Industries, 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.