510(k) · Cleared
ClearedFull Core Biopsy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promex Technologies, LLC · KNW Instrument, Biopsy
Cleared on Sep 6, 2011 as substantially equivalent to K011270 (Promex, Inc., 2001) and 1 other predicate after a 75-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it.
- Decided
- Sep 6, 2011
- Review
- 75 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904987 (1991). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK904987 Vibronics Auto Core Biopsy Device (Acbd)Vibronics · 1991 · Recalled
- This deviceK111765 Full Core Biopsy SystemPromex Technologies, LLC · 2011
- Descendant · cites it directly · 3 of its ownK140137 Safety Biopsy Needle SystemPfm Medical, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK160423 Perineologic Access NeedleCorbin Clinical Resources, LLC · 2016
- Descendant · 3 generations on · 1 of its ownK210946 Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy…Promisemed Hangzhou Meditech Co., Ltd. · 2021
- Descendant · 4 generations on · 0 of its ownK261196 Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026
Most influential descendants
Showing 4 of 4 · See all- K140137Safety Biopsy Needle SystemPfm Medical, Inc. · 2014 · cites it directly3descendants
- K160423Perineologic Access NeedleCorbin Clinical Resources, LLC · 2016 · 2 generations on2descendants
- K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed…Promisemed Hangzhou Meditech Co., Ltd. · 2021 · 3 generations on1descendant
- K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904987 | Vibronics Auto Core Biopsy Device (Acbd) | Vibronics | 1991 | 2 |
| 0 (this device) | K111765 | Full Core Biopsy System | Promex Technologies, LLC | 2011 | — |
| +1 | K140137 | Safety Biopsy Needle System | Pfm Medical, Inc. | 2014 | — |
| +2 | K160423 | Perineologic Access Needle | Corbin Clinical Resources, LLC | 2016 | — |
| +3 | K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices… | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| +4 | 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 |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 KNW? 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 KNW device
- #1 K260572 Marrow Marxmanscore 14.5 · 10 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 |
|---|---|---|---|
| * | K011270 | Automated Core Biopsy DeviceSummary page 1…iopsy Classification Name - Gastroenterology-Urology Biopsy Instrument 21 CFR 876.1075, Product Code FCG Legally Marketed Devices of Equivalence: K01 1270 - SABD M Automated Core Biopsy Device (Promex Technologies, LLC) (the "SABD T Predicate") K904987 - Vibronics Auto Core Biopsy De… | 2001 |
| * | K904987 | Vibronics Auto Core Biopsy Device (Acbd)Summary page 1…876.1075, Product Code FCG Legally Marketed Devices of Equivalence: K01 1270 - SABD M Automated Core Biopsy Device (Promex Technologies, LLC) (the "SABD T Predicate") K904987 - Vibronics Auto Core Biopsy Device (also known as BioPinct Full Core Biopsy Instrument - currently sold by Medical Device Techno… | 1991 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140137 | Safety Biopsy Needle System | 2014 | 3 |
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?
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KNW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNW
1in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · KNW
1,667in 2025
MAUDE reports naming product code KNW, 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 | 6 | 94 | 1 | 766 |
| 2008 | 4 | 53 | 7 | 363 |
| 2009 | 6 | 35 | 3 | 351 |
| 2010 | 3 | 57 | 2 | 162 |
| 2011 | 10 | 64 | 5 | 67 |
| 2012 | 7 | 94 | 1 | 93 |
| 2013 | 3 | 100 | 1 (1) | 98 |
| 2014 | 8 | 95 | 3 | 193 |
| 2015 | 10 | 106 | 0 | 591 |
| 2016 | 9 | 127 | 5 | 297 |
| 2017 | 8 | 90 | 1 | 760 |
| 2018 | 7 | 71 | 0 | 1,012 |
| 2019 | 5 | 94 | 4 | 4,195 |
| 2020 | 8 | 92 | 0 | 5,120 |
| 2021 | 9 | 54 | 3 | 1,020 |
| 2022 | 8 | 203 | 3 | 535 |
| 2023 | 7 | 164 | 2 | 931 |
| 2024 | 5 | 114 | 1 | 1,283 |
| 2025 | 12 | 178 | 0 | 1,667 |
| 2026 | 7 | 29 | 4 (3) | — |
What is it indicated for?
The Full Core Biopsy System 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 for diagnosis only. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the 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/K111765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111765: Full Core Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111765
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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