Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lac Mac, Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
163 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102864 | 84E SERIES SINGLE PLY WRAPPER | Lac Mac, Ltd. | 2011-01-14 | 106 | 0 |
| K092344 | LAC-MAC INNERBLOC LR SURGICAL GOWNS | Lac Mac, Ltd. | 2009-12-17 | 135 | 0 |
| K061491 | LAC-MAC INNERBLOC O.R. GOWN | Lac Mac, Ltd. | 2006-08-09 | 70 | 0 |
| K032631 | INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABL | Lac Mac, Ltd. | 2004-02-05 | 163 | 0 |
| K031362 | LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE RE | Lac Mac, Ltd. | 2003-05-30 | 99 | 0 |
| K030536 | LAC-MAC LIMITED INNERBLOC O.R. GOWN | Lac Mac, Ltd. | 2003-05-06 | 75 | 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