Paragon Medical: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Paragon Medical” (first 2003, latest 2019), across 1 product code in 1 review panel. Median 510(k) review time under this name: 112 days. Since 2017 the median was 127 days, against 150 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 | 0 | — |
| 2015 | 1 | 83 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 147 |
| 2019 | 2 | 108 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Paragon Medical took a median 127 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 5 | 5 |
Review panels
- General Hospital (5)
Most recent Paragon Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190667 | Sonopet iQ Sterilization Tray | KCT | 2019-06-13 | 90 |
| K183701 | Stryker ChestShield Sterilization Tray System | KCT | 2019-05-07 | 127 |
| K173615 | Stryker Universal Select Sterilization Tray System | KCT | 2018-04-18 | 147 |
| K152951 | Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray | KCT | 2015-12-28 | 83 |
| K032119 | PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS | KCT | 2003-10-29 | 112 |
Recalls
openFDA lists no recalls under a recalling firm named Paragon Medical.
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 Trade Brands, Inc. (14 510(k)s)
- Paragon Diagnostics, Inc. (7 510(k)s)
- Paragon Implant Mfg., LLC (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 Medical?
FDA lists 5 510(k) clearances under the applicant name “Paragon Medical” (first 2003, latest 2019), across 1 product code 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 Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Paragon Medical is 112 days. Since 2017: 127 days, versus 150 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Paragon Medical?
The most frequent FDA product codes under this applicant name are KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 5).
Next steps
- See all 5 Paragon Medical clearances with predicates and recalls
- Run predicate analysis for product code KCT, Paragon Medical'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.