510(k) · Cleared
ClearedBiomarc Coaxial Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carbon Medical Technologies, Inc. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on May 13, 2014 as substantially equivalent to K042615 (Carbon Medical Technologies, Inc., 2004) and 1 other predicate after a 208-day review. Its family tree reaches back 4 generations to 1982.
- Decided
- May 13, 2014
- Review
- 208 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K820973 (1982). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK820973 Endoscopic Injection NeedleMill-Rose Laboratory · 1982
- 3 generations backK960519 Martech Endoscopic Injection NeedleMartech Medical Products, Inc. · 1996
- 2 generations backK982890 Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998
- 1 generation backK042615 Carbon Medical Technologies Endoscopic Injection NeedleCarbon Medical Technologies, Inc. · 2004
- This deviceK133148 Biomarc Coaxial NeedleCarbon Medical Technologies, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K820973 | Endoscopic Injection Needle | Mill-Rose Laboratory | 1982 | — |
| −3 | K960519 | Martech Endoscopic Injection Needle | Martech Medical Products, Inc. | 1996 | — |
| −2 | K982890 | Advanced Uroscience Injection Needle | Advanced Uroscience, Inc. | 1998 | — |
| −1 | K042615 | Carbon Medical Technologies Endoscopic Injection Needle | Carbon Medical Technologies, Inc. | 2004 | — |
| 0 (this device) | K133148 | Biomarc Coaxial Needle | Carbon Medical Technologies, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FBK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FBK device
- #1 K253598 InjecSURE Injection Systemscore 12.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042615 | Carbon Medical Technologies Endoscopic Injection NeedleSummary page 1…Implantable Clip, 21 CFR 878.4300, NEU Common/Usual Name: Coaxial Needle Predicate Devices Carbon Medical Technologies Endoscopic Injection Needle (K04261 5), by Carbon Medical Technologies, Inc. Coaxial Biopsy Needle (K936194), by Bard Gynecology & Radiolo… | 2004 |
| * | K936194 | Coaxial Biopsy NeedleSummary page 1…Predicate Devices Carbon Medical Technologies Endoscopic Injection Needle (K04261 5), by Carbon Medical Technologies, Inc. Coaxial Biopsy Needle (K936194), by Bard Gynecology & Radiology Indication for Use The BiomarC Coaxial Needle allows delivery of fiducial m… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K042615.
How does its category compare?
All FBK devicesFBK Endoscopic Injection Needle, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FBK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBK
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FBK
9in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FBK
81in 2025
MAUDE reports naming product code FBK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 22 |
| 2009 | 4 | 101 | 0 | 12 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 9 |
| 2015 | 3 | 103 | 0 | 4 |
| 2016 | 2 | — | 1 | 18 |
| 2017 | 3 | 51 | 0 | 27 |
| 2018 | 2 | — | 0 | 9 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 2 | — | 0 | 25 |
| 2021 | 1 | — | 20 | 34 |
| 2022 | 6 | 213 | 8 | 80 |
| 2023 | 3 | 177 | 1 | 60 |
| 2024 | 4 | 192 | 9 | 94 |
| 2025 | 3 | 155 | 0 | 81 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The BiomnaiC Coaxial Needle allows delivery of fiducial markers into soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133148: Biomarc Coaxial Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133148
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026