510(k) · Cleared
ClearedBMN I Type Marrow Aspiration Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H.S. Hospital Service S.R.L. · KNW Instrument, Biopsy
Cleared on Jun 25, 2002 after a 90-day review. The FDA summary names no predicate by number. 7 later devices descend from it.
- Decided
- Jun 25, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK020987 BMN I Type Marrow Aspiration NeedleH.S. Hospital Service S.R.L. · 2002
- 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) | K020987 | BMN I Type Marrow Aspiration Needle | H.S. Hospital Service S.R.L. | 2002 | — |
| +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?
The FDA summary names no predicate by 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?
This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020987: BMN I Type Marrow Aspiration Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020987
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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