Bio Quantum Technologies, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Bio Quantum Technologies, Inc.” (first 1983, latest 1994), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 141 days. 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 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
| HHR | Laser, Surgical, Gynecologic | 1 | 1 |
| LNK | Laser For Gastro-Urology Use | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Bio Quantum Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934089 | BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S | GEX | 1994-02-03 | 163 |
| K864946 | ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE | HHR | 1988-01-28 | 407 |
| K864887 | ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU | GEX | 1987-04-10 | 119 |
| K864948 | ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE | LNK | 1987-03-30 | 103 |
| K840406 | MICROSURGICAL CO2 LASER SYS - 4100 | GEX | 1984-08-20 | 202 |
| K837110 | MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM | — | 1983-03-11 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Bio Quantum Technologies, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bio Quantum Technologies, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Bio Quantum Technologies, Inc.” (first 1983, latest 1994), across 4 product codes in 3 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 Bio Quantum Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio Quantum Technologies, Inc. is 141 days.
Which FDA product codes appear under Bio Quantum Technologies, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 3); HHR (Laser, Surgical, Gynecologic, 1); LNK (Laser For Gastro-Urology Use, 1).
Next steps
- See all 6 Bio Quantum Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Bio Quantum Technologies, 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.