Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fluke Biomedical — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
180 daysmedian FDA review time
213 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121860 | ESA615 | Fluke Biomedical | 2013-01-25 | 213 | 0 |
| K121722 | ESA620 ELECTRICAL SAFETY ANALYZER | Fluke Biomedical | 2012-10-11 | 121 | 0 |
| K110429 | PROSIM 4, PROSIM 6, PROSIM 8 | Fluke Biomedical | 2011-09-02 | 199 | 0 |
| K103336 | MPS450 MULTIPARAMETER SIMULATOR | Fluke Biomedical | 2011-04-13 | 149 | 0 |
| K083347 | IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS | Fluke Biomedical | 2008-12-24 | 41 | 0 |
| K072114 | IMPULSE 6000D/7000DP | Fluke Biomedical | 2008-01-28 | 180 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda