510(k) · Cleared
ClearedBiopince Ultra Full Core Biopsy Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Device Technologies, Inc. · KNW Instrument, Biopsy
Cleared on Aug 27, 2010 as substantially equivalent to K904987 (Vibronics, 1991) and 3 other predicates after a 57-day review. Its family tree reaches back 4 generations to 1987. 1 later device descends from it.
- Decided
- Aug 27, 2010
- Review
- 57 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K871390 (1987). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
- 3 generations backK962969 Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc. · 1996
- 2 generations backK982085 Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic…Medical Device Technologies, Inc. · 1998
- 1 generation backK982960 Meical Device Technologies, Inc. Tru-Core Disposable Automatic…Medical Device Technologies, Inc. · 1998 · Recalled
- This deviceK101832 Biopince Ultra Full Core Biopsy InstrumentMedical Device Technologies, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK102756 Surecore Biopsy DeviceChest Innovations, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K102756Surecore Biopsy DeviceChest Innovations, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871390 | Bard Biopty Biopsy System | C.R. Bard, Inc. | 1987 | — |
| −3 | K962969 | Medical Device Technologies, Inc.Ultra | Medical Device Technologies, Inc. | 1996 | — |
| −2 | K982085 | Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy… | Medical Device Technologies, Inc. | 1998 | — |
| −1 | K982960 | Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument | Medical Device Technologies, Inc. | 1998 | 2 |
| 0 (this device) | K101832 | Biopince Ultra Full Core Biopsy Instrument | Medical Device Technologies, Inc. | 2010 | — |
| +1 | K102756 | Surecore Biopsy Device | Chest Innovations, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (4)
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 |
|---|---|---|---|
| * | K904987 | Vibronics Auto Core Biopsy Device (Acbd)Summary page 1…21 CFR 876.1075 Class 1I Legally marketed K904987 BioPince~h Full Core Biopsy Instrument devices to which the K982960 TruCore"'m Disposable Automatic Bi… | 1991 |
| * | K982960 | Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy InstrumentSummary page 1…Class 1I Legally marketed K904987 BioPince~h Full Core Biopsy Instrument devices to which the K982960 TruCore"'m Disposable Automatic Biopsy Instrument device is substantially K042464 V-CoreTm Full Core Brea… | 1998 |
| * | K042464 | V-Core Full Core Breast Biopsy InstrumentSummary page 1…opsy Instrument devices to which the K982960 TruCore"'m Disposable Automatic Biopsy Instrument device is substantially K042464 V-CoreTm Full Core Breast Biopsy Instrument equivalent: K050 120 Easy CoreTm Biopsy System… | 2004 |
| * | K050120 | Easy Core Biopsy System IISummary page 1…tic Biopsy Instrument device is substantially K042464 V-CoreTm Full Core Breast Biopsy Instrument equivalent: K050 120 Easy CoreTm Biopsy System Description of the The BioPince Tm Ultra Full Core Biopsy Instrument is a… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102756 | Surecore Biopsy Device | 2011 | 0 |
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 2 companies; a new generation was cleared every 9.5 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K102756 (Chest Innovations, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K904987.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 automatic BioPince Ultra Full Core Biopsy Instrument is intended for multiple percutaneous full-core sampling of soft tissue, tumors, or masses for histological analysis. Soft tissue sampling includes, but is not limited to, kidney, liver, breast, prostate and various soft tissue lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101832 · printed Nov 5, 2026
Cite this page
510(k) Report. “K101832: Biopince Ultra Full Core Biopsy Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101832
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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