Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pm Devices, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063556 | PERIPATCH ENDO-SLEEVE | Pm Devices, Inc. | 2007-03-20 | 113 | 0 |
| K040835 | PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P | Pm Devices, Inc. | 2004-06-15 | 76 | 0 |
| K033985 | PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, | Pm Devices, Inc. | 2004-06-04 | 164 | 0 |
| K031948 | PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 | Pm Devices, Inc. | 2003-09-16 | 84 | 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