Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Busse Hospital Disposables — 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) |
|---|---|---|---|---|---|
| K141285 | BUSSE EXTENSION SET | Busse Hospital Disposables | 2015-02-19 | 279 | 0 |
| K110883 | J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT | Busse Hospital Disposables | 2011-06-08 | 70 | 0 |
| K093920 | BUSSE EPIDURAL CATHETER KIT | Busse Hospital Disposables | 2010-08-06 | 227 | 0 |
| K041464 | BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER | Busse Hospital Disposables | 2004-11-05 | 156 | 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