Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biopsy Sciences, LLC — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
136 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130537 | BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER | Biopsy Sciences, LLC | 2013-03-29 | 28 | 0 |
| K121113 | BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER | Biopsy Sciences, LLC | 2012-07-12 | 91 | 0 |
| K090501 | BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS | Biopsy Sciences, LLC | 2009-03-05 | 8 | 0 |
| K083006 | BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER | Biopsy Sciences, LLC | 2009-02-09 | 124 | 0 |
| K060769 | HYDROMARK BIOPSY SITE MARKER | Biopsy Sciences, LLC | 2006-07-25 | 125 | 0 |
| K041331 | BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER | Biopsy Sciences, LLC | 2004-06-15 | 27 | 0 |
| K023694 | BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANEN | Biopsy Sciences, LLC | 2003-03-17 | 136 | 0 |
| K021847 | BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES | Biopsy Sciences, LLC | 2002-09-03 | 90 | 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