510(k) · Cleared
ClearedMD Tech Biopsy Set for Bone and Bone Marrow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Device Technologies, Inc. · GAA Needle, Aspiration And Injection, Disposable
Cleared on Jul 19, 1996 as substantially equivalent to K890925 (Manan Medical Products, Inc., 1989) and 2 other predicates after a 60-day review. Its family tree reaches back 1 generation to 1989. 1 of the 39 devices in its family, counting itself, has a Class I recall. 35 later devices descend from it.
- Decided
- Jul 19, 1996
- Review
- 60 days
- Class
- Class I
- Product code
- GAA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K890925 (1989). 3 ancestors in all. 35 later devices descend from it, 1 citing it directly. 1 of the 39 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK890925 Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 1989 · Recalled
- This deviceK961959 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 · 2 generations on · 18 of its ownK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005
- Descendant · 2 generations on · 14 of its ownK062833 Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation · 2006
- Descendant · 2 generations on · 14 of its ownK043523 Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005
- Descendant · 3 generations on · 12 of its ownK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013
Showing 5 of 35 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 35 · See all- K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · cites it directly34descendants
- K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Sterylab S.R.L. · 2005 · 2 generations on18descendants
- K062833Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation · 2006 · 2 generations on14descendants
- K043523Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005 · 2 generations on14descendants
- K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890925 | Manan Bone Marrow Biopsy Needle | Manan Medical Products, Inc. | 1989 | 7 |
| 0 (this device) | 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 |
| +2 | K051506 | Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut… | Sterylab S.R.L. | 2005 | — |
| +2 | K062833 | Powered EZ-IO Bone Marrow Aspiration System | Vidacare Corporation | 2006 | — |
| +2 | K043523 | Interv Brand Snarelok Bone Marrow Biopsy Needle | Medical Device Technologies, Inc. | 2005 | — |
| +3 | K131157 | Ranfac Bone Marrow Aspiration Needle | Ranfac, Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 1 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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.
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.
Top candidate predicates for a new GAA device
- #1 K223625 CapnoSpot™ Pneumothorax Decompression Indicatorscore 5.1 · 1 generation · no Class I recall
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K890925 | Manan Bone Marrow Biopsy NeedleSummary page 1…ICATION NAME: Needle, Biopsy, Cardiovascular, No. /79DWO SUBSTANTIAL EQUIVALENCE: Company Name Product Name 510(k) No. Mannan Medical Products Bone Marrow Biopsy Needle K890925 Mannan Medical Products Super Core Biopsy Needle K930732 Mannan Medical Products Bone Marrow Harvest Needle K940023 Sherwood Medi… | 1989 |
| Kept off the family tree | K930732 | FDA’s K930732 is Delfia Cortisol Kit Our OCR of the scanned summary read K930732, FDA’s number for Delfia Cortisol Kit (Wallac OY). Its FDA name has none of the distinctive words the summary uses for the device it names, “Super Core Biopsy Needle”. Kept off the family tree. Summary page 1…SUBSTANTIAL EQUIVALENCE: Company Name Product Name 510(k) No. Mannan Medical Products Bone Marrow Biopsy Needle K890925 Mannan Medical Products Super Core Biopsy Needle K930732 Mannan Medical Products Bone Marrow Harvest Needle K940023 Sherwood Medical Monoject Bone Marrow Needle K945109 LBLLCRIPTION OF… | 1993 |
| * | K940025 | Manan Bone Marrow Harvest Needles Our OCR of the scanned summary read K940023, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Bone Marrow Harvest Needle”. | 1994 |
| * | K945109 | Monoject Bone Marrow Biopsy TraysSummary page 1…K890925 Mannan Medical Products Super Core Biopsy Needle K930732 Mannan Medical Products Bone Marrow Harvest Needle K940023 Sherwood Medical Monoject Bone Marrow Needle K945109 LBLLCRIPTION OF DEVICE: Our company is presently authorized by the Food and Drug Administration to manufacture soft tissue biop… | 1994 |
What descends from it? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980196 | MD Tech Biopsy Set for Bone and Bone Marrow Class I | 1998 | 34 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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?
How does its category compare?
All GAA devicesGAA Needle, Aspiration And Injection, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAA
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GAA
Too few GAA 510(k)s in any year since 2007 to give a median.
Recalls per year · GAA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAA
348in 2025
MAUDE reports naming product code GAA, 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 | 12 |
| 2008 | 0 | — | 1 | 32 |
| 2009 | 0 | — | 2 | 20 |
| 2010 | 0 | — | 2 | 18 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 0 | 33 |
| 2014 | 0 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 32 |
| 2016 | 0 | — | 0 | 45 |
| 2017 | 0 | — | 0 | 85 |
| 2018 | 0 | — | 0 | 122 |
| 2019 | 0 | — | 10 | 153 |
| 2020 | 0 | — | 0 | 102 |
| 2021 | 0 | — | 5 | 108 |
| 2022 | 0 | — | 2 | 74 |
| 2023 | 1 | — | 0 | 118 |
| 2024 | 0 | — | 0 | 181 |
| 2025 | 0 | — | 0 | 348 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MD Tech Biopsy-Set is intended for the purpose of harvesting bone and/or bone marrow specimens.
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/K961959 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961959: MD Tech Biopsy Set for Bone and Bone Marrow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961959
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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