510(k) · Cleared
Recalled · Class II · 2021Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Fusion · KNW Instrument, Biopsy
Cleared on Sep 11, 2017 as substantially equivalent to K813338 (American Pharmaseal Div. Ahsc, 1982) and 3 other predicates after a 109-day review. Its family tree reaches back 4 generations to 1989. 3 later devices descend from it. It has been recalled 6 times.
- Decided
- Sep 11, 2017
- Review
- 109 days
- Class
- Class II
- Product code
- KNW
- Recalls
- 6
- Predicates
- 4
Its longest line of descent runs back 4 generations to K890925 (1989). 9 ancestors in all, the oldest K813338 (1982). 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK890925 Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 1989 · Recalled
- 3 generations backK990515 Mathis Vertebral and Bone Biopsy SystemInternational Medical Systems · 1999
- 2 generations backK032943 Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body…Stryker Corp. · 2003
- 1 generation backK070091 Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208Cardinal Health, Inc. · 2007
- This deviceK171531 Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle…Care Fusion · 2017
- Descendant · cites it directly · 0 of its ownK242322 Bone Marrow Biopsy NeedleZhejiang Curaway Medical Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK192099 MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration…Medax Srl Unipersonale · 2020
- Descendant · cites it directly · 0 of its ownK190177 J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone…Ranfac Corporation · 2019
Most influential descendants
Showing 3 of 3 · See all- K242322Bone Marrow Biopsy NeedleZhejiang Curaway Medical Technology Co., Ltd. · 2025 · cites it directly0descendants
- K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone…Medax Srl Unipersonale · 2020 · cites it directly0descendants
- K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,Ranfac Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890925 | Manan Bone Marrow Biopsy Needle | Manan Medical Products, Inc. | 1989 | 7 |
| −3 | K990515 | Mathis Vertebral and Bone Biopsy System | International Medical Systems | 1999 | — |
| −2 | K032943 | Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone… | Stryker Corp. | 2003 | — |
| −1 | K070091 | Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208 | Cardinal Health, Inc. | 2007 | — |
| 0 (this device) | K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow… | Care Fusion | 2017 | — |
| +1 | K242322 | Bone Marrow Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025 | — |
| +1 | K192099 | MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle… | Medax Srl Unipersonale | 2020 | — |
| +1 | K190177 | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow… | Ranfac Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 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? (4)
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 |
|---|---|---|---|
| * | K813338 | Biopsy Needles & TraysSummary page 4…Urology Regulation Class II per 21CFR §876.1075 Product Code KNW Legally marketed device(s) to K813338, K913306, K003370, and K070091. which equivalence is claimed The Jamshidi® devices are manual, s… | 1982 |
| * | K913306 | Bone-Temno/Sternum-TemnoSummary page 4…egulation Class II per 21CFR §876.1075 Product Code KNW Legally marketed device(s) to K813338, K913306, K003370, and K070091. which equivalence is claimed The Jamshidi® devices are manual, sterile, d… | 1991 |
| * | K003370 | Jamshidi Marrow Acquisition CradleSummary page 4…Class II per 21CFR §876.1075 Product Code KNW Legally marketed device(s) to K813338, K913306, K003370, and K070091. which equivalence is claimed The Jamshidi® devices are manual, sterile, disposable… | 2000 |
| * | K070091 | Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208Summary page 4…Class II per 21CFR §876.1075 Product Code KNW Legally marketed device(s) to K813338, K913306, K003370, and K070091. which equivalence is claimed The Jamshidi® devices are manual, sterile, disposable needles inte… | 2007 |
What descends from it? (3)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 24, 2021 | Class II | Z-0154-2022 | Process control | Due to misbranded products shipped to customers. |
| Aug 24, 2021 | Class II | Z-0153-2022 | Process control | Due to misbranded products shipped to customers. |
| Jun 23, 2021 | Class II | Z-2247-2021 | Packaging process control | Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. |
| Jun 23, 2021 | Class II | Z-2248-2021 | Packaging process control | Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. |
| Mar 17, 2020 | Class II | Z-1689-2020 | Packaging process control | Sterility compromised due to packaging pouches that may not be sealed properly |
| Aug 1, 2019 | Class II | Z-2411-2019 | Packaging process control | Product Pouches may not be sealed properly and compromise the sterility of the device |
The 5 latest of 6 recalls; the web page lists all.
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 10.1 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K242322 (Zhejiang Curaway Medical Technology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K813338.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Jamshidi Bone Marrow Biopsy/Aspiration Needle — DJ: Intended use for the posterior iliac crest biopsy technique.
Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle - TJ: Intended use for the posterior iliac crest biopsy technique.
Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle - EJ: Indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone and/or bone marrow.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171531: Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/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/K171531
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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