510(k) · Cleared
ClearedAutomated Core Biopsy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promex, Inc. · FCG Biopsy Needle
Cleared on Jun 22, 2001 after a 57-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jun 22, 2001
- Review
- 57 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK011270 Automated Core Biopsy DevicePromex, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK111765 Full Core Biopsy SystemPromex Technologies, LLC · 2011
- Descendant · 2 generations on · 3 of its ownK140137 Safety Biopsy Needle SystemPfm Medical, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK160423 Perineologic Access NeedleCorbin Clinical Resources, LLC · 2016
- Descendant · 4 generations on · 1 of its ownK210946 Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy…Promisemed Hangzhou Meditech Co., Ltd. · 2021
- Descendant · 5 generations on · 0 of its ownK261196 Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K111765Full Core Biopsy SystemPromex Technologies, LLC · 2011 · cites it directly4descendants
- K140137Safety Biopsy Needle SystemPfm Medical, Inc. · 2014 · 2 generations on3descendants
- K160423Perineologic Access NeedleCorbin Clinical Resources, LLC · 2016 · 3 generations on2descendants
- K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed…Promisemed Hangzhou Meditech Co., Ltd. · 2021 · 4 generations on1descendant
- K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011270 | Automated Core Biopsy Device | Promex, Inc. | 2001 | — |
| +1 | K111765 | Full Core Biopsy System | Promex Technologies, LLC | 2011 | — |
| +2 | K140137 | Safety Biopsy Needle System | Pfm Medical, Inc. | 2014 | — |
| +3 | K160423 | Perineologic Access Needle | Corbin Clinical Resources, LLC | 2016 | — |
| +4 | K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices… | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| +5 | K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K111765 (Promex Technologies, LLC, 2011) has gone furthest, with 4 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.
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 | — |
https://510kreport.com/device/K011270 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011270: Automated Core Biopsy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011270
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026