# Carbon Medical Technologies, Inc.

- Location (FDA's records): St. Paul, MN
- FDA decisions: 19 (1999–2026): 18 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Carbon Medical Technologies, Inc. (18); Carbon Medical Technologies (1)
- Product codes: NEU (6), IYE (5), FBK (5), LNM (1), FTM (1), GDW (1)
- 510(k) review time since 2016: median 28 days, against 85 for FDA's reviews in the same codes and years (4 of 4 faster)
- Predicates its devices cite: 34 (19 its own); citations of its devices by later devices: 33 (19 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Advanced Uroscience, Inc.: 4 (https://510kreport.com/company/advanced-uroscience)
- Promex, Inc.: 2 (https://510kreport.com/company/promex)
- Civco: 2 (https://510kreport.com/company/civco)
- Tissue Science Laboratories, Plc: 1 (https://510kreport.com/company/tissue-science-laboratories)
- Cook Biotech, Inc.: 1 (https://510kreport.com/company/cook-biotech)
- Uro-1, Inc.: 1 (https://510kreport.com/company/uro-1)
- Medi-Globe Corp.: 1 (https://510kreport.com/company/medi-globe)
- Bard Gynecology and Radiology: 1 (https://510kreport.com/company/bard-gynecology-and-radiology)

## Firms that cite its devices most
- Breast-Med, Inc.: 2 (https://510kreport.com/company/breast-med)
- Scion Medical Technologies, LLC: 2 (https://510kreport.com/company/scion-medical-technologies)
- Focal Therapeutics: 2 (https://510kreport.com/company/focal-therapeutics)
- American Medical Systems, Inc.: 1 (https://510kreport.com/company/american-medical-systems)
- Suros Surgical Systems, Inc. A Hologic Company: 1 (https://510kreport.com/company/suros-surgical-systems-a-hologic)
- Wilson-Cook Medical Inc./Cook Endoscopy: 1 (https://510kreport.com/company/wilson-cook-medical-cook-endoscopy)
- Brennen Medical, Inc.: 1 (https://510kreport.com/company/brennen-medical)
- C4 Imaging, LLC: 1 (https://510kreport.com/company/c4-imaging)

## Its most-cited devices
- K063193: Modification to Biomarc Tissue Marker (2006), cited by 7
- K110772: Biomarc Fiducial Marker (2011), cited by 5
- K042296: Biomarc Preloaded Tissue Marker Device (2004), cited by 4
- K070436: Biomarc Gold Tissue Marker (2007), cited by 4
- K100994: Preloaded Tissue Marker Device (2010), cited by 3
- K021160: Dermmatrix Surgical Mesh (2002), cited by 2

## Recent decisions
- K253598: InjecSURE Injection System (Mar 31, 2026)
- K251748: MammoSTAR Biopsy Site Identifier (Jul 23, 2025)
- K211590: Fiducial Marker (Jun 10, 2021)
- K191797: BiomarC Fiducial Marker (Jul 29, 2019)
- K172227: Endoscopic Injection Needle (Aug 23, 2017)
- K133148: Biomarc Coaxial Needle (May 13, 2014)
- K132064: Biomarc Fiducial Marker (Feb 28, 2014)
- K132708: Biomarc Fiducial Marker (Dec 20, 2013)

Source page: https://510kreport.com/company/carbon-medical-technologies