Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carbon Medical Technologies, Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
38 daysmedian FDA review time
208 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253598 | InjecSURE Injection System | Carbon Medical Technologies, Inc. | 2026-03-31 | 133 | 0 |
| K251748 | MammoSTAR Biopsy Site Identifier | Carbon Medical Technologies, Inc. | 2025-07-23 | 47 | 0 |
| K211590 | Fiducial Marker | Carbon Medical Technologies, Inc. | 2021-06-10 | 17 | 0 |
| K172227 | Endoscopic Injection Needle | Carbon Medical Technologies, Inc. | 2017-08-23 | 29 | 0 |
| K133148 | BIOMARC COAXIAL NEEDLE | Carbon Medical Technologies, Inc. | 2014-05-13 | 208 | 0 |
| K132064 | BIOMARC FIDUCIAL MARKER | Carbon Medical Technologies, Inc. | 2014-02-28 | 240 | 1 |
| K132708 | BIOMARC FIDUCIAL MARKER | Carbon Medical Technologies, Inc. | 2013-12-20 | 113 | 0 |
| K130678 | BIOMARC GOLD FIDUCIAL MARKER | Carbon Medical Technologies, Inc. | 2013-04-12 | 30 | 0 |
| K110772 | BIOMARC FIDUCIAL MARKER | Carbon Medical Technologies, Inc. | 2011-04-28 | 38 | 0 |
| K100994 | PRELOADED TISSUE MARKER DEVICE | Carbon Medical Technologies, Inc. | 2010-04-30 | 21 | 1 |
| K070436 | BIOMARC GOLD TISSUE MARKER | Carbon Medical Technologies, Inc. | 2007-03-16 | 29 | 0 |
| K063193 | MODIFICATION TO BIOMARC TISSUE MARKER | Carbon Medical Technologies, Inc. | 2006-11-21 | 32 | 0 |
| K042615 | CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE | Carbon Medical Technologies, Inc. | 2004-11-05 | 42 | 0 |
| K042296 | BIOMARC PRELOADED TISSUE MARKER DEVICE | Carbon Medical Technologies, Inc. | 2004-09-20 | 27 | 0 |
| K032347 | BIOMARC TISSUE MARKER | Carbon Medical Technologies, Inc. | 2003-08-21 | 22 | 0 |
| K030451 | CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE | Carbon Medical Technologies, Inc. | 2003-04-30 | 78 | 0 |
| K021160 | DERMMATRIX SURGICAL MESH | Carbon Medical Technologies, Inc. | 2002-06-12 | 62 | 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