Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biopsybell S.R.L. · 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) |
|---|---|---|---|---|---|
| K231340 | Renova Spine Balloon Catheter | Biopsybell S.R.L. | 2023-10-30 | 174 | 0 |
| K203397 | Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tr | Biopsybell S.R.L. | 2021-01-11 | 54 | 0 |
| K180315 | DISKOM | Biopsybell S.R.L. | 2018-03-26 | 49 | 0 |
| K130616 | MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEE | Biopsybell S.R.L. | 2014-02-07 | 337 | 1 |
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