Bio-Feedback Systems, Inc.: FDA clearances and approvals
Bio-Feedback Systems, Inc. has 11 FDA 510(k) clearances (first 1977, latest 1991), across 3 product codes in 1 review panel. Median 510(k) review time: 23 days.
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 |
|---|---|---|---|
| HCC | Device, Biofeedback | 9 | 9 |
| GWK | Conditioner, Signal, Physiological | 1 | 1 |
| GWL | Amplifier, Physiological Signal | 1 | 1 |
Review panels
- Neurology (11)
Most recent Bio-Feedback Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905372 | MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002 | HCC | 1991-04-12 | 134 |
| K905373 | MINIATURE TEMPERATURE TRAINER MODEL DT-002 | HCC | 1991-04-10 | 132 |
| K900063 | MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA) | GWL | 1990-02-16 | 44 |
| K860914 | ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV | GWK | 1986-06-06 | 87 |
| K832333 | FEEDBACK EMG SYSTEM PE-020 | HCC | 1983-09-01 | 45 |
| K812619 | ISOLATED VOLTAGE/FREQUENCY CONVERTER | HCC | 1981-10-08 | 23 |
| K792659 | FEEDBACK EDR SYSTEM MODEL ME-1 | HCC | 1980-01-09 | 14 |
| K771023 | ANALOG QUANTIFIER MODEL AQ-100 | HCC | 1977-06-24 | 16 |
| K770790 | FEEDBACK EDR SYSTEM MODEL EDR-100 | HCC | 1977-05-10 | 8 |
| K770663 | FEEDBACK EMG SYSTEM, MODEL PE-L00 | HCC | 1977-04-26 | 19 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bio-Feedback Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bio-Feedback Systems, Inc. have?
Bio-Feedback Systems, Inc. has 11 FDA 510(k) clearances (first 1977, latest 1991), across 3 product codes in 1 review panel.
How long does FDA take to clear Bio-Feedback Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Bio-Feedback Systems, Inc.'s cleared 510(k)s is 23 days.
What devices does Bio-Feedback Systems, Inc. make?
Its most frequent FDA product codes are HCC (Device, Biofeedback, 9); GWK (Conditioner, Signal, Physiological, 1); GWL (Amplifier, Physiological Signal, 1).
Has Bio-Feedback Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bio-Feedback Systems, Inc. Related entities may recall under other names.
Next steps
- See all 11 Bio-Feedback Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HCC, Bio-Feedback Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.