510(k) · Cleared
Recalled · Class II · 2018Manan Bone Marrow Biopsy Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Manan Medical Products, Inc. · DWO Needle, Biopsy, Cardiovascular
Cleared on Apr 11, 1989 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 66 devices in its family, counting itself, has a Class I recall. 65 later devices descend from it. It has been recalled 7 times.
- Decided
- Apr 11, 1989
- Review
- 46 days
- Class
- Class I
- Product code
- DWO
- Recalls
- 7
- Predicates
- 0
65 later devices descend from it, 3 citing it directly. 1 of the 66 devices in this family, counting this one, has a Class I recall.
- This deviceK890925 Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 1989
- Descendant · cites it directly · 35 of its ownK961959 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1996
- Descendant · cites it directly · 34 of its ownK980196 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · Recalled (Class I)
- Descendant · cites it directly · 30 of its ownK990515 Mathis Vertebral and Bone Biopsy SystemInternational Medical Systems · 1999
- Descendant · 2 generations on · 29 of its ownK032943 Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body…Stryker Corp. · 2003
- Descendant · 3 generations on · 18 of its ownK060148 Ebi Vertebroplasty SystemsEbi, L.P. · 2006
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K980196 MD Tech Biopsy Set for Bone and Bone Marrowcites it directly · 1998
Most influential descendants
Showing 5 of 65 · See all- K961959MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1996 · cites it directly35descendants
- K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · cites it directly34descendants
- K990515Mathis Vertebral and Bone Biopsy SystemInternational Medical Systems · 1999 · cites it directly30descendants
- K032943Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy KitsStryker Corp. · 2003 · 2 generations on29descendants
- K060148Ebi Vertebroplasty SystemsEbi, L.P. · 2006 · 3 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K890925 | Manan Bone Marrow Biopsy Needle | Manan Medical Products, Inc. | 1989 | — |
| +1 | K961959 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1996 | — |
| +1 | K980196 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1998 | Class I |
| +1 | 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 | — |
| +3 | K060148 | Ebi Vertebroplasty Systems | Ebi, L.P. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 1 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 9 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (65)
See all 653 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2018 | Class II | Z-0814-2019 | Equipment maintenance | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line |
| Dec 18, 2018 | Class II | Z-0815-2019 | Equipment maintenance | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line |
| Dec 18, 2018 | Class II | Z-0816-2019 | Equipment maintenance | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line |
| Dec 18, 2018 | Class II | Z-0817-2019 | Equipment maintenance | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line |
| Dec 18, 2018 | Class II | Z-0818-2019 | Equipment maintenance | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line |
| Dec 18, 2018 | Class II | Z-0820-2019 | Equipment maintenance | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line |
| Dec 18, 2018 | Class II | Z-0819-2019 | Equipment maintenance | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line |
The 5 latest of 7 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · Cites it directly · ◆ in the 1998 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- Of its descendants, K961959 (Medical Device Technologies, Inc., 1996) has gone furthest, with 35 descendants of its own.
How does its category compare?
All DWO devicesDWO Needle, Biopsy, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWO
FDA has decided no DWO device since 2007.
Median 510(k) review, days · DWO
Too few DWO 510(k)s in any year since 2007 to give a median.
Recalls per year · DWO
7in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWO
6in 2024
MAUDE reports naming product code DWO, 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 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 7 | 9 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K890925 · printed Nov 4, 2026
Cite this page
510(k) Report. “K890925: Manan Bone Marrow Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K890925
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026