510(k) · Cleared
ClearedRP Cutting Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riverpoint Medical · KNW Instrument, Biopsy
Cleared on Sep 24, 2009 after a 79-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Sep 24, 2009
- Review
- 79 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK092059 RP Cutting NeedleRiverpoint Medical · 2009
- Descendant · cites it directly · 2 of its ownK111529 Magnum Core Tissue Biopsy Needle Model MN1820, RP Cutting Needle…Insert Molding Solutions, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK162588 Möller Medical Biopsy Needles and SystemsMoller Medical GmbH · 2017
- Descendant · 3 generations on · 0 of its ownK242128 Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy…Xaga Surgical · 2025
- Descendant · cites it directly · 0 of its ownK201650 VMCore Biopsy NeedleUro-1, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K111529Magnum Core Tissue Biopsy Needle Model MN1820, RP Cutting Needle Model RP-1820, MCN Core…Insert Molding Solutions, Inc. · 2011 · cites it directly2descendants
- K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH · 2017 · 2 generations on1descendant
- K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…Xaga Surgical · 2025 · 3 generations on0descendants
- K201650VMCore Biopsy NeedleUro-1, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092059 | RP Cutting Needle | Riverpoint Medical | 2009 | — |
| +1 | K111529 | Magnum Core Tissue Biopsy Needle Model MN1820, RP Cutting Needle Model… | Insert Molding Solutions, Inc. | 2011 | — |
| +2 | K162588 | Möller Medical Biopsy Needles and Systems | Moller Medical GmbH | 2017 | — |
| +3 | K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and… | Xaga Surgical | 2025 | — |
| +1 | K201650 | VMCore Biopsy Needle | Uro-1, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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? (5)
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 |
|---|---|---|---|
| * | — | Biopty-Cut® Needle Named without a submission number | |
| * | — | Magnum® Needle Named without a submission number | |
| * | — | MLL Needle Named without a submission number | |
| * | — | M-Needle Named without a submission number | |
| * | — | Cook Biopsy Needle Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K111529 (Insert Molding Solutions, Inc., 2011) has gone furthest, with 2 descendants 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. 2009, 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 RP Cutting Needle is intended to be used by medical professionals with the Bard® Magnum® reusable biopsy instrument for biopsies of soft tissues, such as the liver, lung, kidney or prostate. The RP Cutting Needle is not intended for use in bone.
The RP Cutting Needle is provided sterile as a single use device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092059 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092059: RP Cutting Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092059
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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