Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
B&K Medical · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943315 | ULTRASOUND SCANNER 2002 | B&K Medical | 1996-02-09 | 578 | 0 |
| K926332 | DIAGNOSTIC ULTRASOUND SYSTEM, TYPE 3535, MODIFIED | B&K Medical | 1994-06-28 | 589 | 0 |
| K933056 | DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED | B&K Medical | 1994-06-24 | 372 | 0 |
| K802878 | K-KATH URETHRAL CATHETER INTRODUCER | B&K Medical | 1981-01-02 | 46 | 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