510(k) · Cleared
ClearedMonoject Bone Marrow Biopsy Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sherwood Medical Co. · GAA Needle, Aspiration And Injection, Disposable
Cleared on Nov 14, 1994 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 37 devices in its family, counting itself, has a Class I recall. 36 later devices descend from it.
- Decided
- Nov 14, 1994
- Review
- 27 days
- Class
- Class I
- Product code
- GAA
- Recalls
- None
- Predicates
- 0
36 later devices descend from it, 1 citing it directly. 1 of the 37 devices in this family, counting this one, has a Class I recall.
- This deviceK945109 Monoject Bone Marrow Biopsy TraysSherwood Medical Co. · 1994
- Descendant · cites it directly · 35 of its ownK961959 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1996
- Descendant · 2 generations on · 34 of its ownK980196 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · Recalled (Class I)
- Descendant · 3 generations on · 18 of its ownK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005
- Descendant · 3 generations on · 14 of its ownK062833 Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation · 2006
- Descendant · 3 generations on · 14 of its ownK043523 Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K980196 MD Tech Biopsy Set for Bone and Bone Marrow2 generations on · 1998
Most influential descendants
Showing 5 of 36 · 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 · 2 generations on34descendants
- K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Sterylab S.R.L. · 2005 · 3 generations on18descendants
- K062833Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation · 2006 · 3 generations on14descendants
- K043523Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945109 | Monoject Bone Marrow Biopsy Trays | Sherwood Medical Co. | 1994 | — |
| +1 | K961959 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1996 | — |
| +2 | K980196 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1998 | Class I |
| +3 | K051506 | Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut… | Sterylab S.R.L. | 2005 | — |
| +3 | K062833 | Powered EZ-IO Bone Marrow Aspiration System | Vidacare Corporation | 2006 | — |
| +3 | K043523 | Interv Brand Snarelok Bone Marrow Biopsy Needle | Medical Device Technologies, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961959 | MD Tech Biopsy Set for Bone and Bone Marrow | 1996 | 35 |
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 · 2 generations on · ◆ 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 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 | — |
https://510kreport.com/device/K945109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945109: Monoject Bone Marrow Biopsy Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945109
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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