Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
M-Pact Worldwide Management Corp. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971832 | IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EY | M-Pact Worldwide Management Corp. | 1997-07-31 | 73 | 2 |
| K971473 | IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK | M-Pact Worldwide Management Corp. | 1997-07-07 | 75 | 0 |
| K964113 | IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NA | M-Pact Worldwide Management Corp. | 1996-11-07 | 23 | 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