Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Burke, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
40 daysmedian FDA review time
244 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061912 | FUSION | Burke, Inc. | 2006-08-01 | 26 | 0 |
| K023961 | SCOUT BOSS | Burke, Inc. | 2002-12-24 | 25 | 0 |
| K982158 | SCOUT | Burke, Inc. | 1998-08-31 | 73 | 0 |
| K965123 | PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHE | Burke, Inc. | 1997-07-17 | 244 | 0 |
| K911943 | CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM | Burke, Inc. | 1991-07-19 | 79 | 0 |
| K893706 | COLD/HOT FLUID RADIATION PAD NEUTECH | Burke, Inc. | 1989-06-22 | 35 | 0 |
| K834506 | PACESAVER & SCOUT | Burke, Inc. | 1984-01-30 | 40 | 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