Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Padpro, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
291 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020743 | PADPRO, MODEL 2502 | Padpro, LLC | 2002-05-28 | 83 | 0 |
| K020203 | PADPRO MODEL #2516 | Padpro, LLC | 2002-05-08 | 106 | 4 |
| K020288 | PADPRO, MODEL 2603 | Padpro, LLC | 2002-02-27 | 30 | 1 |
| K014209 | PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS | Padpro, LLC | 2002-01-18 | 28 | 4 |
| K003548 | PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS | Padpro, LLC | 2001-09-04 | 291 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda