510(k) · Cleared
Recalled · Class II · 2023Bard Mission Disposable Core Biopsy Instrument
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 Sep 14, 2017 as substantially equivalent to K161409 (Mermaid Medical A/S, 2016) and 1 other predicate after a 77-day review. Its family tree reaches back 3 generations to 1995. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 14, 2017
- Review
- 77 days
- Class
- Class II
- Product code
- KNW
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 3 generations to K950732 (1995). 5 ancestors in all, the oldest K922939 (1993). 5 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK950732 Manan Super-Core Biopsy NeedleManan Medical Products, Inc. · 1995
- 2 generations backK974814 Manan (TM) Super-Core Biopsy NeedlesMedical Device Technologies, Inc. · 1998 · Recalled
- 1 generation backK161409 M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial…Mermaid Medical A/S · 2016
- This deviceK171953 Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK222865 M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy…Canyon Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK250032 Marquee™ Disposable Core Biopsy Instrument and Instrument KitBard Peripheral Vascular, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK241793 Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy…Zhejiang Curaway Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK233031 M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy…Canyon Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK201166 Temno Elite Biopsy SystemMerit Medical Systems, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K222865M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic…Canyon Medical, Inc. · 2023 · cites it directly1descendant
- K250032Marquee™ Disposable Core Biopsy Instrument and Instrument KitBard Peripheral Vascular, Inc. · 2025 · cites it directly0descendants
- K241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable…Zhejiang Curaway Medical Technology Co., Ltd. · 2025 · cites it directly0descendants
- K233031M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic…Canyon Medical, Inc. · 2024 · 2 generations on0descendants
- K201166Temno Elite Biopsy SystemMerit Medical Systems, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950732 | Manan Super-Core Biopsy Needle | Manan Medical Products, Inc. | 1995 | — |
| −2 | K974814 | Manan (TM) Super-Core Biopsy Needles | Medical Device Technologies, Inc. | 1998 | 1 |
| −1 | K161409 | M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle… | Mermaid Medical A/S | 2016 | — |
| 0 (this device) | K171953 | Bard Mission Disposable Core Biopsy Instrument | Bard Peripheral Vascular, Inc. | 2017 | — |
| +1 | K222865 | M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore… | Canyon Medical, Inc. | 2023 | — |
| +1 | K250032 | Marquee™ Disposable Core Biopsy Instrument and Instrument Kit | Bard Peripheral Vascular, Inc. | 2025 | — |
| +1 | K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/… | Zhejiang Curaway Medical Technology Co., Ltd. | 2025 | — |
| +2 | K233031 | M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore… | Canyon Medical, Inc. | 2024 | — |
| +1 | K201166 | Temno Elite Biopsy System | Merit Medical Systems, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K161409 | M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemSummary page 4…stroenterology / Urology Regulation Number: 21 CFR 876.1075 Predicate Devices: x M-Biopsy™ Semi-Automatic Biopsy Instrument by Mermaid Medical (K161409; cleared 2 August 2016) x BARD® MONOPTY® and BARD® MAX-CORE® Disposable Core Biopsy Instruments (K133948/S001; cleared… | 2016 |
| * | K133948 | Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable…Summary page 4…Automatic Biopsy Instrument by Mermaid Medical (K161409; cleared 2 August 2016) x BARD® MONOPTY® and BARD® MAX-CORE® Disposable Core Biopsy Instruments (K133948/S001; cleared 21 February 2014) Reference Devices: y POWERGLIDE® Midline Catheter (K121073; cleared 1 June 2012) y ULTRAC… | 2014 |
| † | K121073 | Powerglide Midline Catheter | 2012 |
| † | K042341 | Ultraclip II US | 2004 |
| † | K051158 | Encor 7 Gauge | 2005 |
| † | K131493 | Sidekick and Usher Support Catheters | 2013 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222865 | M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic… | 2023 | 1 |
| K250032 | Marquee™ Disposable Core Biopsy Instrument and Instrument Kit | 2025 | 0 |
| K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable… | 2025 | 0 |
| K201166 | Temno Elite Biopsy System | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2023 | Class II | Z-0643-2024 | Process control | The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit… |
| Apr 11, 2023 | Class II | Z-1564-2023 | Mixed-up of materials/components | Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue… |
| Feb 28, 2023 | Class II | Z-1260-2023 | Mixed-up of materials/components | The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K222865 (Canyon Medical, Inc., 2023) has gone furthest, with 1 descendant 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. 2017, 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 Bard® Mission® Disposable Core Biopsy Instrument is intended for use in obtaining biopsy samples from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171953: Bard Mission Disposable Core Biopsy Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171953
Report an extraction error
Are you the manufacturer?
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