510(k) · Cleared
ClearedPerineologic Access Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corbin Clinical Resources, LLC · FCG Biopsy Needle
Cleared on Sep 2, 2016 as substantially equivalent to K936194 (Bard Gynecology and Radiology, 1994) and 1 other predicate after a 199-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- Sep 2, 2016
- Review
- 199 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K904987 (1991). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK904987 Vibronics Auto Core Biopsy Device (Acbd)Vibronics · 1991 · Recalled
- 2 generations backK111765 Full Core Biopsy SystemPromex Technologies, LLC · 2011
- 1 generation backK140137 Safety Biopsy Needle SystemPfm Medical, Inc. · 2014
- This deviceK160423 Perineologic Access NeedleCorbin Clinical Resources, LLC · 2016
- Descendant · cites it directly · 1 of its ownK210946 Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy…Promisemed Hangzhou Meditech Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK261196 Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904987 | Vibronics Auto Core Biopsy Device (Acbd) | Vibronics | 1991 | 2 |
| −2 | K111765 | Full Core Biopsy System | Promex Technologies, LLC | 2011 | — |
| −1 | K140137 | Safety Biopsy Needle System | Pfm Medical, Inc. | 2014 | — |
| 0 (this device) | K160423 | Perineologic Access Needle | Corbin Clinical Resources, LLC | 2016 | — |
| +1 | K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices… | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| +2 | 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 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K936194 | Coaxial Biopsy NeedleSummary page 5…the following predicate devices which have been determined by FDA to be substantially equivalent to the following devices: Bard TrueGuideTM Coaxial Biopsy Needle Guide (K936194) and the PFM Medical Biopsy Needle System (K140137); Class II medical devices that were cleared for marketing in the United State… | 1994 |
| * | K140137 | Safety Biopsy Needle SystemSummary page 5…termined by FDA to be substantially equivalent to the following devices: Bard TrueGuideTM Coaxial Biopsy Needle Guide (K936194) and the PFM Medical Biopsy Needle System (K140137); Class II medical devices that were cleared for marketing in the United States under K936194 and K140137 respectively. === Page… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed… | 2021 | 1 |
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 25 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K210946 (Promisemed Hangzhou Meditech Co., Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K936194.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Perineologic Access Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue and tumors of such organs as liver, kidney, spleen, lymph nodes, prostate, lung and various soft tissue lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160423: Perineologic Access Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160423
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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