Bio-Logic Systems Corp.: FDA clearances and approvals
Bio-Logic Systems Corp. has 45 FDA 510(k) clearances (first 1981, latest 2012), across 15 product codes in 3 review panels. Median 510(k) review time: 86 days. openFDA lists 2 product recalls by a recalling firm named Bio-Logic Systems Corp.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 72 |
| 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 |
|---|---|---|---|
| EWO | Audiometer | 9 | 9 |
| GWJ | Stimulator, Auditory, Evoked Response | 7 | 7 |
| GWQ | Full-Montage Standard Electroencephalograph | 5 | 5 |
| GWE | Stimulator, Photic, Evoked Response | 4 | 4 |
| GWF | Stimulator, Electrical, Evoked Response | 3 | 3 |
| OLV | Standard Polysomnograph With Electroencephalograph | 3 | 3 |
| GWK | Conditioner, Signal, Physiological | 2 | 2 |
| GWN | Nystagmograph | 2 | 2 |
| GXY | Electrode, Cutaneous | 2 | 2 |
| IKN | Electromyograph, Diagnostic | 2 | 2 |
Plus 5 more product codes.
Review panels
- Neurology (32)
- Ear, Nose and Throat (10)
- Anesthesiology (3)
Most recent Bio-Logic Systems Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122496 | AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | EWO | 2012-11-01 | 77 |
| K121512 | SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM | EWO | 2012-07-26 | 66 |
| K073626 | BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM | GWJ | 2008-02-05 | 41 |
| K061744 | COCHLEA-SCAN / COCHLEA-SCAN PLUS | EWO | 2006-09-15 | 86 |
| K052066 | CEEGRAPH/SLEEPSCAN NETLINK TRAVELER | OLV | 2005-08-26 | 25 |
| K031352 | BIO-LOGIC INSERT EARPHONES | EWO | 2003-07-16 | 78 |
| K030907 | STACKED ABR FOR NAVIGATOR PRO | GWJ | 2003-05-09 | 46 |
| K031009 | MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM | GWJ | 2003-04-28 | 28 |
| K021895 | BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM | GWJ | 2002-07-01 | 21 |
| K021801 | BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS | EWO | 2002-06-27 | 24 |
35 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2007-07-26.
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-Logic Systems Corp. have?
Bio-Logic Systems Corp. has 45 FDA 510(k) clearances (first 1981, latest 2012), across 15 product codes in 3 review panels.
How long does FDA take to clear Bio-Logic Systems Corp.'s 510(k)s?
The median time from FDA receipt to decision across Bio-Logic Systems Corp.'s cleared 510(k)s is 86 days.
What devices does Bio-Logic Systems Corp. make?
Its most frequent FDA product codes are EWO (Audiometer, 9); GWJ (Stimulator, Auditory, Evoked Response, 7); GWQ (Full-Montage Standard Electroencephalograph, 5).
Has Bio-Logic Systems Corp. had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Bio-Logic Systems Corp; the most recent began 2007-07-26. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 45 Bio-Logic Systems Corp. clearances with predicates and recalls
- Run predicate analysis for product code EWO, Bio-Logic Systems Corp.'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.