Paragon Trade Brands, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Paragon Trade Brands, Inc.” (first 1995, latest 1998), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 72 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 |
|---|---|---|---|
| HHD | Pad, Menstrual, Unscented | 8 | 8 |
| HEB | Tampon, Menstrual, Unscented | 3 | 3 |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | 3 | 3 |
Review panels
Most recent Paragon Trade Brands, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983381 | VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS | HEB | 1998-10-19 | 24 |
| K981953 | VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS | HEB | 1998-08-18 | 76 |
| K962962 | DEODORANT PANTY LINER | HHL | 1996-10-10 | 72 |
| K962954 | DEODORANT MAXI PAD | HHL | 1996-10-10 | 72 |
| K962953 | DEODORANT PANTY SHIELD | HHL | 1996-10-10 | 72 |
| K953333 | MENSTRUAL TAMPON | HEB | 1995-12-06 | 142 |
| K953668 | UNSCENTED ULTRATHIN MAXI PAD | HHD | 1995-11-01 | 86 |
| K953667 | UNSCENTED CURVED ULTRATHIN MAXI PADS | HHD | 1995-11-01 | 86 |
| K953553 | UNSCENTED MENSTRAL PAD | HHD | 1995-10-27 | 91 |
| K953517 | UNSCENTED MENSTRUAL PAD | HHD | 1995-10-26 | 91 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Paragon Trade Brands, 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.
- Paragon 28, Inc. (60 510(k)s)
- Paragon Vision Sciences (16 510(k)s)
- Paragon Diagnostics, Inc. (7 510(k)s)
- Paragon Implant Mfg., LLC (5 510(k)s)
- Paragon Medical (5 510(k)s)
- Paragon Optical Co. (1 510(k)s)
- Paragon Bioteck, Inc. (1 510(k)s)
- Paragon Medical and Scientific, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Paragon Trade Brands, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Paragon Trade Brands, Inc.” (first 1995, latest 1998), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Paragon Trade Brands, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Paragon Trade Brands, Inc. is 72 days.
Which FDA product codes appear under Paragon Trade Brands, Inc.?
The most frequent FDA product codes under this applicant name are HHD (Pad, Menstrual, Unscented, 8); HEB (Tampon, Menstrual, Unscented, 3); HHL (Pad, Menstrual, Scented, Scented-Deodorized, 3).
Next steps
- See all 14 Paragon Trade Brands, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HHD, Paragon Trade Brands, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.