510(k) · Cleared
ClearedMagnum Core Tissue Biopsy Needle Model MN1820, RP Cutting Needle Model RP-1820, MCN Core Tissue Biopsy Needle Model MCN-
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insert Molding Solutions, Inc. · KNW Instrument, Biopsy
Cleared on Jul 29, 2011 as substantially equivalent to K092059 (Riverpoint Medical, 2009) and 2 other predicates after a 57-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.
- Decided
- Jul 29, 2011
- Review
- 57 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K883469 (1989). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK883469 Bard (R) Aspiration Biopsy SystemC.R. Bard, Inc. · 1989
- This deviceK111529 Magnum Core Tissue Biopsy Needle Model MN1820, RP Cutting Needle…Insert Molding Solutions, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK162588 Möller Medical Biopsy Needles and SystemsMoller Medical GmbH · 2017
- Descendant · 2 generations on · 0 of its ownK242128 Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy…Xaga Surgical · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883469 | Bard (R) Aspiration Biopsy System | C.R. Bard, Inc. | 1989 | — |
| 0 (this device) | K111529 | Magnum Core Tissue Biopsy Needle Model MN1820, RP Cutting Needle Model… | Insert Molding Solutions, Inc. | 2011 | — |
| +1 | K162588 | Möller Medical Biopsy Needles and Systems | Moller Medical GmbH | 2017 | — |
| +2 | K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and… | Xaga Surgical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K092059 | RP Cutting NeedleSummary page 1…biopsy instrument, needle (21 CFR 876.1075, Product Code KNW) Name of Predicate(s) or Legally Marketed Device(s) K092059 - Riverpoint Medical RP Cutting Needle K883469 -C.R. Bard®D Aspiration Biopsy System ("Magnum®")… | 2009 |
| * | K883469 | Bard (R) Aspiration Biopsy SystemSummary page 1…oduct Code KNW) Name of Predicate(s) or Legally Marketed Device(s) K092059 - Riverpoint Medical RP Cutting Needle K883469 -C.R. Bard®D Aspiration Biopsy System ("Magnum®") K994272- Promex MCN Automated Core Biopsy Device De… | 1989 |
| * | K994272 | Automated Core Biopsy DeviceSummary page 1…K092059 - Riverpoint Medical RP Cutting Needle K883469 -C.R. Bard®D Aspiration Biopsy System ("Magnum®") K994272- Promex MCN Automated Core Biopsy Device Device Description The M-CORE disposable core biopsy needle is a sterile, disposable b… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162588 | Möller Medical Biopsy Needles and Systems | 2017 | 1 |
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?
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 M-CORE disposable biopsy needle is intended for use with the Bard® Magnum® biopsy instrument in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The M-CORE needle is not intended for use in bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111529: Magnum Core Tissue Biopsy Needle Model MN1820, RP Cutting Needle Model RP-1820, MCN Core Tissue Biopsy Needle Model MCN-.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111529
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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