Carbon Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Carbon Medical Technologies, Inc.” (first 2002, latest 2026), plus 1 PMA decision, across 6 product codes in 3 review panels. Median 510(k) review time under this name: 35 days. Since 2017 the median was 29 days, against 114 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 72 |
| 2014 | 2 | 224 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 29 |
| 2018 | 0 | — |
| 2019 | 1 | 26 |
| 2020 | 0 | — |
| 2021 | 1 | 17 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 47 |
| 2026 | 1 | 133 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Carbon Medical Technologies, Inc. took a median 29 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | 6 | 6 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 5 | 5 |
| IYE | Accelerator, Linear, Medical | 5 | 5 |
| FTM | Mesh, Surgical | 1 | 1 |
| GDW | Staple, Implantable | 1 | 1 |
| LNM | Agent, Bulking, Injectable For Gastro-Urology Use | 1 | 0 |
Review panels
Most recent Carbon Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253598 | InjecSURE Injection System | FBK | 2026-03-31 | 133 |
| K251748 | MammoSTAR Biopsy Site Identifier | NEU | 2025-07-23 | 47 |
| K211590 | Fiducial Marker | IYE | 2021-06-10 | 17 |
| K191797 | BiomarC Fiducial Marker | IYE | 2019-07-29 | 26 |
| K172227 | Endoscopic Injection Needle | FBK | 2017-08-23 | 29 |
| K133148 | BIOMARC COAXIAL NEEDLE | FBK | 2014-05-13 | 208 |
| K132064 | BIOMARC FIDUCIAL MARKER | IYE | 2014-02-28 | 240 |
| K132708 | BIOMARC FIDUCIAL MARKER | NEU | 2013-12-20 | 113 |
| K130678 | BIOMARC GOLD FIDUCIAL MARKER | IYE | 2013-04-12 | 30 |
| K110772 | BIOMARC FIDUCIAL MARKER | IYE | 2011-04-28 | 38 |
8 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P980053 | PMA | DURASPHERE INJECTABLE BULKING AGENT | 1999-09-13 |
Recalls
2 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2024-07-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Carbon Medical Technologies, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Carbon (Shenzhen) Medical Device Co., Ltd. (2 510(k)s)
- Carbon, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Carbon Medical Technologies, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Carbon Medical Technologies, Inc.” (first 2002, latest 2026), plus 1 PMA decision, across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Carbon Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carbon Medical Technologies, Inc. is 35 days. Since 2017: 29 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Carbon Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are NEU (Marker, Radiographic, Implantable, 6); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 5); IYE (Accelerator, Linear, Medical, 5).
Next steps
- See all 18 Carbon Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NEU, Carbon Medical Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.