Biotex, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Biotex, Inc.” (first 2006, latest 2024), across 5 product codes in 5 review panels. Median 510(k) review time under this name: 116 days. Since 2017 the median was 211 days, against 108 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 164 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 211 |
| 2022 | 0 | — |
| 2023 | 1 | 164 |
| 2024 | 1 | 216 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biotex, Inc. took a median 211 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| OCX | Endoscopic Irrigation/Suction System | 2 | 2 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 1 | 1 |
| LQZ | Device, Jaw Repositioning | 1 | 1 |
Review panels
- General and Plastic Surgery (4)
- Gastroenterology and Urology (2)
- Radiology (2)
- Dental (1)
- Neurology (1)
Most recent Biotex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233442 | troCarWash System | OCX | 2024-05-21 | 216 |
| K222695 | troCarWash System | OCX | 2023-02-17 | 164 |
| K203712 | The Slide | LQZ | 2021-07-20 | 211 |
| K161704 | Phasor Drill | HBE | 2016-12-01 | 164 |
| K092197 | PHOTEX30 DIODE LASER SERIES: 980, 810, 940 | GEX | 2009-10-06 | 77 |
| K081656 | VISUALASE THERMAL THERAPY SYSTEM | LLZ | 2008-09-10 | 90 |
| K071328 | VISUALASE THERMAL THERAPY SYSTEM | GEX | 2007-08-31 | 112 |
| K063505 | VISUALASE ENVISION SOFTWARE SYSTEM | LLZ | 2006-12-12 | 22 |
| K060304 | PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 | GEX | 2006-03-21 | 43 |
| K053087 | VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM | GEX | 2006-03-01 | 119 |
Recalls
openFDA lists no recalls under a recalling firm named Biotex, 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 Biotex, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06533163: Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial (Recruiting, started 2025-02-17)
- NCT01065948: A Feasibility Study to Assess Critical Aspects of Fluorescence Affinity Sensor (FAS) Performance and Safety Over Several Hours (Completed, started 2009-11)
- NCT00392119: MR Guided Laser Interstitial Thermal Therapy for the "Minimal Invasive" Treatment of Brain Metastasis and Primary Brain Tumors (Completed, started 2006-10)
- NCT00392366: Laser Interstitial Thermal Therapy Under "Real Time" MRI Guidance for "Minimal Invasive" Treatment of Liver Metastasis (Completed, started 2006-07)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biotex, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Biotex, Inc.” (first 2006, latest 2024), across 5 product codes in 5 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 Biotex, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biotex, Inc. is 116 days. Since 2017: 211 days, versus 108 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biotex, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 4); LLZ (System, Image Processing, Radiological, 2); OCX (Endoscopic Irrigation/Suction System, 2).
Next steps
- See all 10 Biotex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Biotex, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.