Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mpm Medical., Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
255 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060340 | ORAMAGIC PLUS ORAL WOUND RINSE | Mpm Medical., Inc. | 2006-05-10 | 89 | 0 |
| K024180 | ORAMAGICRX ORAL WOUND RINSE | Mpm Medical., Inc. | 2003-03-14 | 86 | 0 |
| K020540 | REGENECARE WOUND GEL | Mpm Medical., Inc. | 2002-11-01 | 255 | 0 |
| K992074 | MPM REGENECARE WOUND GEL | Mpm Medical., Inc. | 1999-12-23 | 188 | 0 |
| K962160 | MPM HYDROGEL DRESSING (NON-STERILE) | Mpm Medical., Inc. | 1996-06-26 | 22 | 0 |
| K952276 | MPM HYDROGEL DRESSING | Mpm Medical., Inc. | 1995-06-30 | 46 | 0 |
| K942798 | MPM HYDROGEL | Mpm Medical., Inc. | 1994-07-11 | 26 | 0 |
| K930560 | MPM HYDROGEL SATURATED DRESSING | Mpm Medical., Inc. | 1993-07-08 | 155 | 0 |
| K926044 | MPM WET DRESSING (SALINE) | Mpm Medical., Inc. | 1993-04-08 | 128 | 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