FDA applicant
BTL Industries, Inc.
FDA records 47 decisions for BTL Industries, Inc. (Marlborough, MA) from 2009 to 2026: 47 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and PBX (Massager, Vacuum, Radio Frequency Induced Heat). Since 2016 its 510(k)s took a median of 140 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 78 predicates, 29 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Btl Industries, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided BTL Industries, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like BTL Industries, Inc.’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