Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MJG · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
96 daysmedian FDA review time
287 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080674 | PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM | PAJUNK GmbH Medizintechnologie | 2008-05-09 | 60 | 0 |
| K070836 | EXICLIP EXCS-M | Clevex, Inc. | 2007-04-20 | 24 | 0 |
| K983647 | ECHO-COAT ULTRASOUND NEEDLES | Sts Biopolymers | 1999-01-20 | 96 | 0 |
| K955683 | RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY | Contour Fabricators of Florida, Inc. | 1996-02-01 | 49 | 0 |
| K933324 | SKIN BIOPSY DEVICE | Nhr, Inc. | 1994-03-31 | 262 | 0 |
| K925870 | SPACER | Bip USA, Inc. | 1993-05-19 | 181 | 0 |
| K922919 | DYNACYT BIOPSY ASPIRATION DEVICE | Buckman Co., Inc. | 1993-03-31 | 287 | 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