Lac Mac, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Lac Mac, Ltd.” (first 2003, latest 2011), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 102 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FYA | Gown, Surgical | 4 | 4 |
| FRG | Wrap, Sterilization | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Lac Mac, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102864 | 84E SERIES SINGLE PLY WRAPPER | FRG | 2011-01-14 | 106 |
| K092344 | LAC-MAC INNERBLOC LR SURGICAL GOWNS | FYA | 2009-12-17 | 135 |
| K061491 | LAC-MAC INNERBLOC O.R. GOWN | FYA | 2006-08-09 | 70 |
| K032631 | INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X) | FYA | 2004-02-05 | 163 |
| K031362 | LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS | KKX | 2003-05-30 | 99 |
| K030536 | LAC-MAC LIMITED INNERBLOC O.R. GOWN | FYA | 2003-05-06 | 75 |
Recalls
openFDA lists no recalls under a recalling firm named Lac Mac, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Lac Mac, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Lac Mac, Ltd.” (first 2003, latest 2011), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lac Mac, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lac Mac, Ltd. is 102 days.
Which FDA product codes appear under Lac Mac, Ltd.?
The most frequent FDA product codes under this applicant name are FYA (Gown, Surgical, 4); FRG (Wrap, Sterilization, 1); KKX (Drape, Surgical, Antimicrobial, 1).
Next steps
- See all 6 Lac Mac, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FYA, Lac Mac, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.