510(k) · Cleared
ClearedM Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canyon Medical, Inc. · KNW Instrument, Biopsy
Cleared on Apr 3, 2023 as substantially equivalent to K133948 (Bard Peripheral Vascular, Inc., 2014) and 1 other predicate after a 193-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Apr 3, 2023
- Review
- 193 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). 1 later device descends from it, 1 citing it directly.
- 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 deviceK222865 M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy…Canyon Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK233031 M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy…Canyon Medical, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233031M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic…Canyon Medical, Inc. · 2024 · cites it directly0descendants
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) | K222865 | M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore… | Canyon Medical, Inc. | 2023 | — |
| +1 | K233031 | M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore… | Canyon Medical, Inc. | 2024 | — |
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 |
|---|---|---|
| 2024 | 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 4. Predicate Device(s) Information: Subject device Predicate device Automatic Disposable K133948 BARD® MAX-CORE® Disposable Core Biopsy Biopsy Needle Instrument Semi-automatic Disposable K171953 BARD® MISSI… | 2014 |
| * | K171953 | Bard Mission Disposable Core Biopsy InstrumentSummary page 5…Predicate device Automatic Disposable K133948 BARD® MAX-CORE® Disposable Core Biopsy Biopsy Needle Instrument Semi-automatic Disposable K171953 BARD® MISSION® Disposable Core Biopsy Biopsy Needle Instrument K171953 BARD® TRUGUI… | 2017 |
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 |
|---|---|---|---|
| K233031 | M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic… | 2024 | 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 28 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K233031 (Canyon Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 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. 2023, 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?
Automatic Disposable Biopsy Needle: Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone. Semi-automatic Disposable Biopsy Needle: Semi-Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is…
Read the full statement (115 words)
Automatic Disposable Biopsy Needle:
Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.
Semi-automatic Disposable Biopsy Needle:
Semi-Automatic Disposable Biopsy Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.
Coaxial Biopsy Needle:
Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for use in bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222865 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222865: M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222865
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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