Padpro, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Padpro, LLC” (first 2001, latest 2002), across 1 product code in 1 review panel. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Padpro, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020743 | PADPRO, MODEL 2502 | MKJ | 2002-05-28 | 83 |
| K020203 | PADPRO MODEL #2516 | MKJ | 2002-05-08 | 106 |
| K020288 | PADPRO, MODEL 2603 | MKJ | 2002-02-27 | 30 |
| K014209 | PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS | MKJ | 2002-01-18 | 28 |
| K003548 | PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS | MKJ | 2001-09-04 | 291 |
Recalls
openFDA lists no recalls under a recalling firm named Padpro, LLC.
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 Padpro, LLC?
FDA lists 5 510(k) clearances under the applicant name “Padpro, LLC” (first 2001, latest 2002), 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 Padpro, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Padpro, LLC is 83 days.
Which FDA product codes appear under Padpro, LLC?
The most frequent FDA product codes under this applicant name are MKJ (Automated External Defibrillators (Non-Wearable), 5).
Next steps
- See all 5 Padpro, LLC clearances with predicates and recalls
- Run predicate analysis for product code MKJ, Padpro, LLC'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.