BTL Industries, Inc.: FDA filings under this applicant name
FDA lists 46 510(k) clearances under the applicant name “BTL Industries, Inc.” (first 2009, latest 2026), across 17 product codes in 6 review panels. Median 510(k) review time under this name: 175 days. Since 2017 the median was 160 days, against 114 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 267 |
| 2013 | 1 | 195 |
| 2014 | 1 | 253 |
| 2015 | 6 | 152 |
| 2016 | 4 | 171 |
| 2017 | 2 | 78 |
| 2018 | 4 | 120 |
| 2019 | 3 | 130 |
| 2020 | 0 | — |
| 2021 | 1 | 86 |
| 2022 | 3 | 189 |
| 2023 | 5 | 212 |
| 2024 | 5 | 140 |
| 2025 | 4 | 230 |
| 2026 | 4 | 181 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name BTL Industries, Inc. took a median 160 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 14 | 14 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 5 | 5 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 4 | 4 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 3 | 3 |
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 2 | 2 |
| OBP | Transcranial Magnetic Stimulator | 2 | 2 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 1 | 1 |
Plus 7 more product codes.
Review panels
- General and Plastic Surgery (23)
- Physical Medicine (13)
- Neurology (5)
- Gastroenterology and Urology (3)
- Cardiovascular (1)
- Dental (1)
Most recent BTL Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260691 | BTL-699 | OBP | 2026-08-23 | 173 |
| K252963 | BTL-899TT | IMJ | 2026-06-12 | 268 |
| K253750 | BTL-785NEH | GEI | 2026-03-17 | 112 |
| K252561 | BTL-754FF | GEX | 2026-02-18 | 189 |
| K250309 | BTL-199 | QPL | 2025-08-07 | 185 |
| K243290 | BTL-785MJ | NUW | 2025-05-09 | 203 |
| K241516 | BTL-398 | KPI | 2025-02-10 | 257 |
| K241270 | BTL-754 | GEX | 2025-01-30 | 269 |
| K242532 | BTL-785BNF-E | NFO | 2024-12-13 | 109 |
| K240234 | BTL-899MS | IPF | 2024-08-17 | 201 |
36 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named BTL Industries, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named BTL Industries, Inc. is the lead sponsor of 57 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT07413692: BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Urinary Incontinence in Postpartum and Early Post-Childbirth Women (Recruiting, started 2025-11-25)
- NCT07413705: BTL-699-2 and HPM-6000UF Devices for the Improvement of Depressive Symptoms and Sexual Function Among Perimenopausal and Postmenopausal Women (Recruiting, started 2025-11-20)
- NCT07179224: EEG Changes After rTMS Stimulation (Completed, started 2025-09-17)
- NCT07024550: Impact of the EXOMIND (BTL-699-2) on the Brain Reward Pathway (Active not recruiting, started 2025-07-22)
- NCT07027657: EXOMIND (BTL-699-2) for the Improvement of Sleep Quality and Reduction of Stress (Completed, started 2025-05-02)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under BTL Industries, Inc. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Frequently asked questions
How many FDA 510(k) clearances are listed under BTL Industries, Inc.?
FDA lists 46 510(k) clearances under the applicant name “BTL Industries, Inc.” (first 2009, latest 2026), across 17 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by BTL Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name BTL Industries, Inc. is 175 days. Since 2017: 160 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under BTL Industries, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 14); PBX (Massager, Vacuum, Radio Frequency Induced Heat, 5); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 4).
Next steps
- See all 46 BTL Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, BTL Industries, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.