Pdg Product Design Group, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Pdg Product Design Group, Inc.” (first 1996, latest 2017), across 1 product code in 1 review panel. Median 510(k) review time under this name: 27 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 | 1 | 283 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 202 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 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 Pdg Product Design Group, Inc. took a median 202 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | 8 | 8 |
Review panels
Most recent Pdg Product Design Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163432 | Stellar LEAP | IOR | 2017-06-27 | 202 |
| K140023 | ELEVATION | IOR | 2014-10-16 | 283 |
| K063736 | FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50 | IOR | 2007-01-17 | 30 |
| K061475 | ASTROTILT MANUAL WHEELCHAIR | IOR | 2006-06-14 | 15 |
| K990557 | THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR | IOR | 1999-03-22 | 28 |
| K971389 | ECLIPSE 400 MANUALLY OPERATED WHEELCAIR | IOR | 1997-05-09 | 25 |
| K970311 | BENTLEY MANUALLY OPERATED WHEELCHAIR | IOR | 1997-02-14 | 18 |
| K961743 | ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR | IOR | 1996-05-29 | 26 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2012-06-12.
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 Pdg Product Design Group, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Pdg Product Design Group, Inc.” (first 1996, latest 2017), 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 Pdg Product Design Group, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pdg Product Design Group, Inc. is 27 days.
Which FDA product codes appear under Pdg Product Design Group, Inc.?
The most frequent FDA product codes under this applicant name are IOR (Wheelchair, Mechanical, 8).
Next steps
- See all 8 Pdg Product Design Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IOR, Pdg Product Design Group, 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.