510(k) · Cleared
ClearedK-C Hemostatic Biopsy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioengineering Consultants, Ltd. · FCG Biopsy Needle
Cleared on Jul 13, 2005 as substantially equivalent to P010049 (Sub-Q, Inc., 2002) after a 173-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Jul 13, 2005
- Review
- 173 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P010049 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backP010049 Quickseal Femoral Arterial Closure SystemSub-Q, Inc. · 2002
- This deviceK050135 K-C Hemostatic Biopsy SystemBioengineering Consultants, Ltd. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P010049 | Quickseal Femoral Arterial Closure System | Sub-Q, Inc. | 2002 | — |
| 0 (this device) | K050135 | K-C Hemostatic Biopsy System | Bioengineering Consultants, Ltd. | 2005 | — |
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 FCG? 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 FCG device
- #1 K250994 ClearTip FNA and FNB Typesscore 13.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | P010049 | Quickseal Femoral Arterial Closure SystemSummary page 2…es: QuickSeal Arterial Closure System Sub-Q Inc. (San Clemente, CA) FDA # P0 10049 Aspiration Needles a. Modified MENGHINI Needle for Aspiration Biops… | 2002 |
| * | — | Modified MENGHINI Needle for Aspiration Biopsy Named without a submission number | |
| * | — | Jamshidi Menghini soft Tissue Biopsy Tray Named without a submission number | |
| * | — | Jamshidi Soft Tissue Biopsy Needle/Syringe Named without a submission number | |
| * | — | Bard Max-Core Disposible Biopsy System Named without a submission number | |
| * | — | Temno Biopsy System Named without a submission number | |
| * | — | Coaxial Quick-Core Biopsy Sets Named without a submission number | |
| * | — | ASAPTM Automated Biopsy System Named without a submission number |
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?
- Its one ancestor has no recall.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCG
82in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FCG
5in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCG
632in 2025
MAUDE reports naming product code FCG, 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 | 4 | 32 | 0 | 11 |
| 2008 | 1 | — | 19 | 115 |
| 2009 | 4 | 87 | 5 | 270 |
| 2010 | 3 | 18 | 4 | 73 |
| 2011 | 1 | — | 2 | 71 |
| 2012 | 0 | — | 0 | 107 |
| 2013 | 1 | — | 0 | 130 |
| 2014 | 5 | 88 | 0 | 154 |
| 2015 | 4 | 91 | 0 | 124 |
| 2016 | 3 | 63 | 0 | 191 |
| 2017 | 3 | 166 | 0 | 273 |
| 2018 | 6 | 140 | 0 | 282 |
| 2019 | 0 | — | 0 | 229 |
| 2020 | 1 | — | 0 | 240 |
| 2021 | 1 | — | 5 | 290 |
| 2022 | 2 | — | 0 | 302 |
| 2023 | 4 | 82 | 0 | 428 |
| 2024 | 1 | — | 0 | 446 |
| 2025 | 2 | — | 0 | 632 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The K-C Hemostatic Biopsy System is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs/tumors or masses for histological analysis and deliver a hemostatic material to the biopsy site to reduce bleeding from the biopsy site. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate. It is not intended for use in bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050135 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050135: K-C Hemostatic Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050135
Report an extraction error
Are you the manufacturer?
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