510(k) · Cleared
ClearedSafety Biopsy Needle System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pfm Medical, Inc. · FCG Biopsy Needle
Cleared on Mar 25, 2014 as substantially equivalent to K111765 (Promex Technologies, LLC, 2011) and 1 other predicate after a 62-day review. Its family tree reaches back 2 generations to 1991. 3 later devices descend from it.
- Decided
- Mar 25, 2014
- Review
- 62 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K904987 (1991). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK904987 Vibronics Auto Core Biopsy Device (Acbd)Vibronics · 1991 · Recalled
- 1 generation backK111765 Full Core Biopsy SystemPromex Technologies, LLC · 2011
- This deviceK140137 Safety Biopsy Needle SystemPfm Medical, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK160423 Perineologic Access NeedleCorbin Clinical Resources, LLC · 2016
- Descendant · 2 generations on · 1 of its ownK210946 Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy…Promisemed Hangzhou Meditech Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK261196 Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026
Most influential descendants
Showing 3 of 3 · See all- K160423Perineologic Access NeedleCorbin Clinical Resources, LLC · 2016 · cites it directly2descendants
- K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed…Promisemed Hangzhou Meditech Co., Ltd. · 2021 · 2 generations on1descendant
- K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904987 | Vibronics Auto Core Biopsy Device (Acbd) | Vibronics | 1991 | 2 |
| −1 | K111765 | Full Core Biopsy System | Promex Technologies, LLC | 2011 | — |
| 0 (this device) | K140137 | Safety Biopsy Needle System | Pfm Medical, Inc. | 2014 | — |
| +1 | K160423 | Perineologic Access Needle | Corbin Clinical Resources, LLC | 2016 | — |
| +2 | K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices… | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| +3 | K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K111765 | Full Core Biopsy SystemSummary page 1…es, LLC (US Biopsy) Address: 9001 Wesleyan Road Indianapolis, IN 46268 Name: Full Core Biopsy System 51 0(k) # K1 11765 Manufacturer VLV Associates, Inc Address: 30-C Ridgedale East Hanover, NJ 07936 Name:… | 2011 |
| * | K933364 | Promed Biopsy NeedleSummary page 1…VLV Associates, Inc Address: 30-C Ridgedale East Hanover, NJ 07936 Name: Promed Biopsy Needle 51 0(k) # K933364 Device Description The Safety Biopsy Needle System consists of two main components: The Safety Biopsy Needle and the Safety Coa… | 1994 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160423 | Perineologic Access Needle | 2016 | 2 |
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 23 years and passes through 3 companies; a new generation was cleared every 20.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K160423 (Corbin Clinical Resources, LLC, 2016) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 Safety Biopsy Needle System (Safety Biopsy Needle and Safety Coaxial Needle with Finger Guard) is intended to be used for soft tissue and tumor biopsy of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes. When used for breast biopsy, the product is far diagnosis only. The extent of histological abnormality cannot be reliably determined from its mamnmographic appearance. Therefore, the extent of removal of the imaged…
Read the full statement (114 words)
The Safety Biopsy Needle System (Safety Biopsy Needle and Safety Coaxial Needle with Finger Guard) is intended to be used for soft tissue and tumor biopsy of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes.
When used for breast biopsy, the product is far diagnosis only. The extent of histological abnormality cannot be reliably determined from its mamnmographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality; e.g., malignancy. When sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal of using standard surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140137 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140137: Safety Biopsy Needle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140137
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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