510(k) · Cleared
Recalled · Class II · 2024Vibronics Auto Core Biopsy Device (Acbd)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vibronics · KNW Instrument, Biopsy
Cleared on Feb 11, 1991 after a 96-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 11, 1991
- Review
- 96 days
- Class
- Class II
- Product code
- KNW
- Recalls
- 2
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK904987 Vibronics Auto Core Biopsy Device (Acbd)Vibronics · 1991
- 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 · cites it directly · 2 of its ownK090611 Revolution Full Core BiopsyInrad · 2009
- Descendant · 4 generations on · 1 of its ownK210946 Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy…Promisemed Hangzhou Meditech Co., Ltd. · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · 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
- K090611Revolution Full Core BiopsyInrad · 2009 · cites it directly2descendants
- K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed…Promisemed Hangzhou Meditech Co., Ltd. · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904987 | Vibronics Auto Core Biopsy Device (Acbd) | Vibronics | 1991 | — |
| +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 | — |
| +1 | K090611 | Revolution Full Core Biopsy | Inrad | 2009 | — |
| +4 | K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices… | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2024 | Class II | Z-3192-2024 | Packaging change control | Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious… |
| Dec 2, 2019 | Class II | Z-2427-2020 | Labeling Change Control | Incorrect product labeling. |
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 KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.
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) | — |
https://510kreport.com/device/K904987 · printed Nov 4, 2026
Cite this page
510(k) Report. “K904987: Vibronics Auto Core Biopsy Device (Acbd).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904987
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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