Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BTL Industries, Inc. — Predicate Candidate Screening
42 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
177 daysmedian FDA review time
284 days90th percentile
42clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252963 | BTL-899TT | BTL Industries, Inc. | 2026-06-12 | 268 | 0 |
| K253750 | BTL-785NEH | BTL Industries, Inc. | 2026-03-17 | 112 | 0 |
| K252561 | BTL-754FF | BTL Industries, Inc. | 2026-02-18 | 189 | 0 |
| K250309 | BTL-199 | BTL Industries, Inc. | 2025-08-07 | 185 | 0 |
| K243290 | BTL-785MJ | BTL Industries, Inc. | 2025-05-09 | 203 | 0 |
| K241516 | BTL-398 | BTL Industries, Inc. | 2025-02-10 | 257 | 0 |
| K241270 | BTL-754 | BTL Industries, Inc. | 2025-01-30 | 269 | 0 |
| K242532 | BTL-785BNF-E | BTL Industries, Inc. | 2024-12-13 | 109 | 0 |
| K240234 | BTL-899MS | BTL Industries, Inc. | 2024-08-17 | 201 | 0 |
| K233849 | BTL-499 | BTL Industries, Inc. | 2024-04-23 | 140 | 0 |
| K233604 | BTL-785S | BTL Industries, Inc. | 2024-03-28 | 140 | 0 |
| K230657 | BTL-99-OC | BTL Industries, Inc. | 2024-02-01 | 329 | 0 |
| K232937 | BTL-899M | BTL Industries, Inc. | 2023-12-26 | 97 | 0 |
| K230467 | BTL-899F | BTL Industries, Inc. | 2023-09-21 | 212 | 0 |
| K232172 | BTL-785BNF Handpiece | BTL Industries, Inc. | 2023-09-18 | 59 | 0 |
| K222556 | BTL-785X | BTL Industries, Inc. | 2023-05-31 | 281 | 0 |
| K221865 | BTL-094 | BTL Industries, Inc. | 2023-04-14 | 291 | 0 |
| K211639 | BTL-785W | BTL Industries, Inc. | 2022-03-07 | 284 | 0 |
| K212723 | BTL-995-rTMS | BTL Industries, Inc. | 2022-03-04 | 189 | 0 |
| K213344 | BTL-899A | BTL Industries, Inc. | 2022-01-05 | 90 | 0 |
| K211107 | BTL-899 FP | BTL Industries, Inc. | 2021-07-09 | 86 | 0 |
| K190456 | BTL 799-2L | BTL Industries, Inc. | 2019-07-05 | 130 | 0 |
| K190023 | BTL-084 | BTL Industries, Inc. | 2019-03-29 | 84 | 0 |
| K182363 | BTL-703 | BTL Industries, Inc. | 2019-01-24 | 147 | 0 |
| K180359 | BTL-FR2000 | BTL Industries, Inc. | 2018-12-13 | 307 | 0 |
| K181497 | HPM-6000UF | BTL Industries, Inc. | 2018-11-14 | 160 | 0 |
| K182106 | BTL 799-2T | BTL Industries, Inc. | 2018-10-23 | 81 | 0 |
| K180813 | BTL 799-2 | BTL Industries, Inc. | 2018-06-14 | 77 | 0 |
| K163165 | AM-100 | BTL Industries, Inc. | 2017-02-16 | 98 | 0 |
| K163176 | Exilis XP II | BTL Industries, Inc. | 2017-01-12 | 59 | 0 |
| K162010 | HPM-6000U | BTL Industries, Inc. | 2016-12-13 | 146 | 0 |
| K160992 | HPM-6000 | BTL Industries, Inc. | 2016-10-21 | 196 | 0 |
| K161551 | TR-100 | BTL Industries, Inc. | 2016-09-13 | 102 | 0 |
| K152731 | XP1100 RF | BTL Industries, Inc. | 2016-07-20 | 302 | 0 |
| K150353 | BTL-4000 | BTL Industries, Inc. | 2015-11-13 | 275 | 0 |
| K150720 | XP3000 | BTL Industries, Inc. | 2015-09-16 | 181 | 0 |
| K143559 | XP1000 RF | BTL Industries, Inc. | 2015-06-11 | 177 | 0 |
| K150051 | Exilite | BTL Industries, Inc. | 2015-04-08 | 86 | 0 |
| K143109 | XP300 | BTL Industries, Inc. | 2015-03-06 | 128 | 0 |
| K143040 | Exilis XP | BTL Industries, Inc. | 2015-01-15 | 85 | 0 |
| K120093 | BTL ELITE | BTL Industries, Inc. | 2012-10-05 | 267 | 0 |
| K100310 | BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT | BTL Industries, Inc. | 2010-10-13 | 252 | 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