FDA applicant
Lac Mac, Ltd.
FDA records 6 decisions for Lac Mac, Ltd. (Austin, TX) from 2003 to 2011: 6 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and FRG (Wrap, Sterilization). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Lac Mac, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2007high 1 (2009) · low 0 (2007)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Lac Mac, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report