Fluke Biomedical: FDA clearances and approvals
Fluke Biomedical has 6 FDA 510(k) clearances (first 2008, latest 2013), across 2 product codes in 1 review panel. Median 510(k) review time: 164 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 121 |
| 2013 | 1 | 213 |
| 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 4 | 4 |
| DRL | Tester, Defibrillator | 2 | 2 |
Review panels
- Cardiovascular (6)
Most recent Fluke Biomedical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121860 | ESA615 | DRT | 2013-01-25 | 213 |
| K121722 | ESA620 ELECTRICAL SAFETY ANALYZER | DRT | 2012-10-11 | 121 |
| K110429 | PROSIM 4, PROSIM 6, PROSIM 8 | DRT | 2011-09-02 | 199 |
| K103336 | MPS450 MULTIPARAMETER SIMULATOR | DRT | 2011-04-13 | 149 |
| K083347 | IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS | DRL | 2008-12-24 | 41 |
| K072114 | IMPULSE 6000D/7000DP | DRL | 2008-01-28 | 180 |
Recalls
openFDA lists no recalls under a recalling firm named Fluke Biomedical.
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 Fluke Biomedical have?
Fluke Biomedical has 6 FDA 510(k) clearances (first 2008, latest 2013), across 2 product codes in 1 review panel.
How long does FDA take to clear Fluke Biomedical's 510(k)s?
The median time from FDA receipt to decision across Fluke Biomedical's cleared 510(k)s is 164 days.
What devices does Fluke Biomedical make?
Its most frequent FDA product codes are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 4); DRL (Tester, Defibrillator, 2).
Has Fluke Biomedical had device recalls?
openFDA lists no recalls under a recalling firm name matching Fluke Biomedical. Related entities may recall under other names.
Next steps
- See all 6 Fluke Biomedical clearances with predicates and recalls
- Run predicate analysis for product code DRT, Fluke Biomedical'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.