510(k) Report

FDA applicant

Carbon Medical Technologies, Inc.

St. Paul, MN19 decisions1999–20262 recalls

FDA records 19 decisions for Carbon Medical Technologies, Inc. (St. Paul, MN) from 1999 to 2026: 18 510(k) clearances and 1 original PMA approval. Most are in product codes NEU (Marker, Radiographic, Implantable) and IYE (Accelerator, Linear, Medical). Since 2016 its 510(k)s took a median of 28 days from receipt to decision, against 85 for FDA’s reviews in the same codes and years. Its devices cite 34 predicates, 19 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Carbon Medical Technologies”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Carbon Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 12010: 12011: 12013: 22014: 22017: 12019: 12021: 12025: 12026 (partial year): 1
2007high 2 (2013) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2024

2022: 12024: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Carbon Medical Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Carbon Medical Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NEUMarker, Radiographic, Implantable6decisions
  • IYEAccelerator, Linear, Medical5decisions
  • FBKEndoscopic Injection Needle, Gastroenterology-Urology5decisions
  • LNMAgent, Bulking, Injectable For Gastro-Urology Use1decision
  • FTMMesh, Surgical1decision
  • GDWStaple, Implantable1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 28 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 85 days; 4 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 34 predicates; 19 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 33 times; 19 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K063193Modification to Biomarc Tissue MarkerCarbon Medical Technologies, Inc. · 20067cite it
  • K110772Biomarc Fiducial MarkerCarbon Medical Technologies, Inc. · 20115cite it
  • K042296Biomarc Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 20044cite it
  • K070436Biomarc Gold Tissue MarkerCarbon Medical Technologies, Inc. · 20074cite it
  • K100994Preloaded Tissue Marker DeviceCarbon Medical Technologies, Inc. · 20103cite it
  • K021160Dermmatrix Surgical MeshCarbon Medical Technologies, Inc. · 20022cite it

What has FDA decided for it lately?

  • K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc. · 2026
  • K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc. · 2025
  • K211590Fiducial MarkerCarbon Medical Technologies, Inc. · 2021
  • K191797BiomarC Fiducial MarkerCarbon Medical Technologies · 2019
  • K172227Endoscopic Injection NeedleCarbon Medical Technologies, Inc. · 2017
  • K133148Biomarc Coaxial NeedleCarbon Medical Technologies, Inc. · 2014
  • K132064Biomarc Fiducial MarkerCarbon Medical Technologies, Inc. · 20141 recall
  • K132708Biomarc Fiducial MarkerCarbon Medical Technologies, Inc. · 2013

All 18 as Carbon Medical Technologies, Inc. →The one decision as Carbon Medical Technologies →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K132064BiomarC EX Fiducial Marker System, Catalog Number 040165Jul 26, 2024Class III
  • K100994Mammotome MammoStar Biopsy Site Identified, REF STAR1401Dec 16, 2022Class II

Other applicant names beginning “Carbon”

FDA records each applicant name separately; these may or may not be the same firm.

Carbon (Shenzhen) Medical Device Co., Ltd. 2Carbon, Inc. 1