510(k) · Cleared
ClearedRanfac Goldenberg Snarecoil Soft Tissue Biopsy (GSS) Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ranfac, Corp. · KNW Instrument, Biopsy
Cleared on May 23, 2003 after a 24-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- May 23, 2003
- Review
- 24 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK031344 Ranfac Goldenberg Snarecoil Soft Tissue Biopsy (GSS) NeedleRanfac, Corp. · 2003
- Descendant · cites it directly · 6 of its ownK121181 Swannshidi Bone Marrow Aspiration NeedleAlliance Partners, LLC · 2012
- Descendant · 2 generations on · 5 of its ownK140991 Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014
- Descendant · 3 generations on · 4 of its ownK150563 Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015
- Descendant · 4 generations on · 1 of its ownK223612 Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation · 2023
- Descendant · 4 generations on · 1 of its ownK202287 Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K121181Swannshidi Bone Marrow Aspiration NeedleAlliance Partners, LLC · 2012 · cites it directly6descendants
- K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014 · 2 generations on5descendants
- K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015 · 3 generations on4descendants
- K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation · 2023 · 4 generations on1descendant
- K202287Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation · 2020 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031344 | Ranfac Goldenberg Snarecoil Soft Tissue Biopsy (GSS) Needle | Ranfac, Corp. | 2003 | — |
| +1 | K121181 | Swannshidi Bone Marrow Aspiration Needle | Alliance Partners, LLC | 2012 | — |
| +2 | K140991 | Ranfac Aspiration Needle with Adjustable Guide | Ranfac, Corp. | 2014 | — |
| +3 | K150563 | Marrow Cellution Bone Marrow Aspiration Needle | Ranfac, Corp. | 2015 | — |
| +4 | K223612 | Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) | Ranfac Corporation | 2023 | — |
| +4 | K202287 | Ran-Flex-B Bone Marrow Aspiration Needle | Ranfac Corporation | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Ranfac Single Action Biopsy Needle Named without a submission number | |
| * | — | Ranfac Goldenberg Bone Marrow Biopsy Needle Named without a submission number | |
| * | — | Ethicon Endo-Surgery Inc. Mammotome Hand Held 11 Gauge Biopsy Probe Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121181 | Swannshidi Bone Marrow Aspiration Needle | 2012 | 6 |
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, K121181 (Alliance Partners, LLC, 2012) has gone furthest, with 6 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.
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 GSS Biopsy Needle is intended for obtaining a percutaneous soft tissue biopsy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031344 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031344: Ranfac Goldenberg Snarecoil Soft Tissue Biopsy (GSS) Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031344
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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