510(k) · Cleared
ClearedMarquee™ Disposable Core Biopsy Instrument and Instrument Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Peripheral Vascular, Inc. · KNW Instrument, Biopsy
Cleared on Jul 10, 2025 as substantially equivalent to K133948 (Bard Peripheral Vascular, Inc., 2014) and 1 other predicate after a 184-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Jul 10, 2025
- Review
- 184 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K950732 (1995). 6 ancestors in all, the oldest K922939 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK950732 Manan Super-Core Biopsy NeedleManan Medical Products, Inc. · 1995
- 3 generations backK974814 Manan (TM) Super-Core Biopsy NeedlesMedical Device Technologies, Inc. · 1998 · Recalled
- 2 generations backK161409 M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial…Mermaid Medical A/S · 2016
- 1 generation backK171953 Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. · 2017 · Recalled
- This deviceK250032 Marquee™ Disposable Core Biopsy Instrument and Instrument KitBard Peripheral Vascular, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950732 | Manan Super-Core Biopsy Needle | Manan Medical Products, Inc. | 1995 | — |
| −3 | K974814 | Manan (TM) Super-Core Biopsy Needles | Medical Device Technologies, Inc. | 1998 | 1 |
| −2 | K161409 | M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle… | Mermaid Medical A/S | 2016 | — |
| −1 | K171953 | Bard Mission Disposable Core Biopsy Instrument | Bard Peripheral Vascular, Inc. | 2017 | 3 |
| 0 (this device) | K250032 | Marquee™ Disposable Core Biopsy Instrument and Instrument Kit | Bard Peripheral Vascular, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K133948 | Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable…Summary page 5…Gastroenterology / Urology Regulation Number: 21 CFR 876.1075 Predicate Devices: Bard® Monopty® Disposable Core Biopsy Instrument (K133948, cleared February 21, 2014) Bard® Mission® Disposable Core Biopsy Instrument and Instrument Kit (K171953, cl… | 2014 |
| * | K171953 | Bard Mission Disposable Core Biopsy InstrumentSummary page 5…Bard® Monopty® Disposable Core Biopsy Instrument (K133948, cleared February 21, 2014) Bard® Mission® Disposable Core Biopsy Instrument and Instrument Kit (K171953, cleared September 14, 2017) Device Description: The Marquee™ Disposable Core Biopsy Instrument and Instrument Kit is a s… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 12 other devices also cite its predicate K133948.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Marquee™ Disposable Core Biopsy Instrument and Kit are intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250032 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250032: Marquee™ Disposable Core Biopsy Instrument and Instrument Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250032
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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