Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list BTL Industries with 51 510(k) clearances. The most recent is a 510(k) clearance dated Sep 23, 2026: BTL-299-F.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 23, 2026 | BTL-299-FK262353 · KPI | 510(k) clearances |
| Aug 23, 2026 | BTL-699K260691 · OBP | 510(k) clearances |
| Jun 12, 2026 | BTL-899TTK252963 · IMJ | 510(k) clearances |
| Mar 17, 2026 | BTL-785NEHK253750 · GEI | 510(k) clearances |
| Feb 18, 2026 | BTL-754FFK252561 · GEX | 510(k) clearances |
| Aug 7, 2025 | BTL-199K250309 · QPL | 510(k) clearances |
| May 9, 2025 | BTL-785MJK243290 · NUW | 510(k) clearances |
| Feb 10, 2025 | BTL-398K241516 · KPI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
