Company ยท US
BTL Industries, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2026. Name variants (Inc, Corp, punctuation) are merged.
47510(k) clearances (5 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 14 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 5 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 4 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 4 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 3 |
| IPF | Stimulator, Muscle, Powered | 3 |
| GEX | Powered Laser Surgical Instrument | 2 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 2 |
| OBP | Transcranial Magnetic Stimulator | 2 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 1 |
| ISA | Massager, Therapeutic, Electric | 1 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 1 |
| NUW | Stimulator, Muscle, Powered, Dental | 1 |
| OLI | Fat Reducing Low Level Laser | 1 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 1 |
| QCI | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | 1 |
| QPL | Electromagnetic Stimulator, Pain Relief | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 2026 | K262353 | BTL-299-F BTL Industries, Inc. | KPI |
| Aug 23, 2026 | K260691 | BTL-699 BTL Industries, Inc. | OBP |
| Jun 12, 2026 | K252963 | BTL-899TT BTL Industries, Inc. | IMJ |
| Mar 17, 2026 | K253750 | BTL-785NEH BTL Industries, Inc. | GEI |
| Feb 18, 2026 | K252561 | BTL-754FF BTL Industries, Inc. | GEX |
| Aug 7, 2025 | K250309 | BTL-199 BTL Industries, Inc. | QPL |
| May 9, 2025 | K243290 | BTL-785MJ BTL Industries, Inc. | NUW |
| Feb 10, 2025 | K241516 | BTL-398 BTL Industries, Inc. | KPI |
| Jan 30, 2025 | K241270 | BTL-754 BTL Industries, Inc. | GEX |
| Dec 13, 2024 | K242532 | BTL-785BNF-E BTL Industries, Inc. | NFO |
| Aug 17, 2024 | K240234 | BTL-899MS BTL Industries, Inc. | IPF |
| Apr 23, 2024 | K233849 | BTL-499 BTL Industries, Inc. | GEI |
| Mar 28, 2024 | K233604 | BTL-785S BTL Industries, Inc. | GEI |
| Feb 1, 2024 | K230657 | BTL-99-OC BTL Industries, Inc. | QCI |
| Dec 26, 2023 | K232937 | BTL-899M BTL Industries, Inc. | IPF |
| Sep 21, 2023 | K230467 | BTL-899F BTL Industries, Inc. | GEI |
| Sep 18, 2023 | K232172 | BTL-785BNF Handpiece BTL Industries, Inc. | NFO |
| May 31, 2023 | K222556 | BTL-785X BTL Industries, Inc. | GEI |
| Apr 14, 2023 | K221865 | BTL-094 BTL Industries, Inc. | ISA |
| Mar 7, 2022 | K211639 | BTL-785W BTL Industries, Inc. | GEI |
| Mar 4, 2022 | K212723 | BTL-995-rTMS BTL Industries, Inc. | OBP |
| Jan 5, 2022 | K213344 | BTL-899A BTL Industries, Inc. | GEI |
| Jul 9, 2021 | K211107 | BTL-899 FP BTL Industries, Inc. | GEI |
| Jul 5, 2019 | K190456 | BTL 799-2L BTL Industries, Inc. | NGX |
| Mar 29, 2019 | K190023 | BTL-084 BTL Industries, Inc. | PBX |
| Jan 24, 2019 | K182363 | BTL-703 BTL Industries, Inc. | IMJ |
| Dec 13, 2018 | K180359 | BTL-FR2000 BTL Industries, Inc. | GEI |
| Nov 14, 2018 | K181497 | HPM-6000UF BTL Industries, Inc. | KPI |
| Oct 23, 2018 | K182106 | BTL 799-2T BTL Industries, Inc. | NGX |
| Jun 14, 2018 | K180813 | BTL 799-2 BTL Industries, Inc. | NGX |
| Feb 16, 2017 | K163165 | AM-100 BTL Industries, Inc. | NGX |
| Jan 12, 2017 | K163176 | Exilis XP II BTL Industries, Inc. | PBX |
| Dec 13, 2016 | K162010 | HPM-6000U BTL Industries, Inc. | KPI |
| Oct 21, 2016 | K160992 | HPM-6000 BTL Industries, Inc. | IPF |
| Sep 13, 2016 | K161551 | TR-100 BTL Industries, Inc. | PBX |
| Jul 20, 2016 | K152731 | XP1100 RF BTL Industries, Inc. | GEI |
| Nov 13, 2015 | K150353 | BTL-4000 BTL Industries, Inc. | IMG |
| Sep 16, 2015 | K150720 | XP3000 BTL Industries, Inc. | PBX |
| Jun 11, 2015 | K143559 | XP1000 RF BTL Industries, Inc. | GEI |
| Apr 8, 2015 | K150051 | Exilite BTL Industries, Inc. | ONF |
| Mar 6, 2015 | K143109 | XP300 BTL Industries, Inc. | GEI |
| Jan 15, 2015 | K143040 | Exilis XP BTL Industries, Inc. | PBX |
| Sep 10, 2014 | K134040 | BTL-9000; BTL-9000 RADIOFREQUENCY MODULE Btl Industries, Ltd. | OLI |
| Apr 8, 2013 | K122966 | XP200 Btl Industries, Ltd. | GEI |
| Oct 5, 2012 | K120093 | BTL ELITE BTL Industries, Inc. | IMJ |
| Oct 13, 2010 | K100310 | BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS BTL Industries, Inc. | MWJ |
| Nov 25, 2009 | K092191 | EXILIS, MODEL 5000 Btl Industries, Ltd. | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||