Galix Biomedical Instrumentation, Inc.: FDA clearances and approvals
Galix Biomedical Instrumentation, Inc. has 6 FDA 510(k) clearances (first 1998, latest 2010), across 5 product codes in 1 review panel. Median 510(k) review time: 270 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 |
|---|---|---|---|
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| DTE | Pulse-Generator, Pacemaker, External | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Galix Biomedical Instrumentation, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092853 | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM | MLO | 2010-07-09 | 296 |
| K051163 | GALIX ECG PROFESSIONAL STATION | DPS | 2006-01-31 | 271 |
| K030145 | GALIX WINTER | DQK | 2003-09-17 | 245 |
| K023080 | GALIX PACESTAR | DTE | 2003-06-11 | 267 |
| K992706 | GALIX GBI -3S-LP | MLO | 2001-03-15 | 581 |
| K971670 | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER | DSH | 1998-01-29 | 268 |
Recalls
openFDA lists no recalls under a recalling firm named Galix Biomedical Instrumentation, 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 Galix Biomedical Instrumentation, Inc. have?
Galix Biomedical Instrumentation, Inc. has 6 FDA 510(k) clearances (first 1998, latest 2010), across 5 product codes in 1 review panel.
How long does FDA take to clear Galix Biomedical Instrumentation, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Galix Biomedical Instrumentation, Inc.'s cleared 510(k)s is 270 days.
What devices does Galix Biomedical Instrumentation, Inc. make?
Its most frequent FDA product codes are MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm, 2); DPS (Electrocardiograph, 1); DQK (Computer, Diagnostic, Programmable, 1).
Has Galix Biomedical Instrumentation, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Galix Biomedical Instrumentation, Inc. Related entities may recall under other names.
Next steps
- See all 6 Galix Biomedical Instrumentation, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MLO, Galix Biomedical Instrumentation, 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.