510(k) · Cleared
ClearedModified Intended Use of Monoject Bone Marrow Need
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 Jul 28, 1988 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jul 28, 1988
- Review
- 9 days
- Class
- Class I
- Product code
- GAA
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK883014 Modified Intended Use of Monoject Bone Marrow NeedSherwood Medical Co. · 1988
- Descendant · cites it directly · 7 of its ownK970380 F.a.S.T. 1 Intraosseous Infusion SystemPyng Medical Corp. · 1997
- Descendant · 2 generations on · 4 of its ownK072487 FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008
- Descendant · 3 generations on · 3 of its ownK080865 FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008
- Descendant · 4 generations on · 2 of its ownK100124 Fastx Sternal Intraosseous DevicePyng Medical Corp. · 2010 · Recalled
- Descendant · 4 generations on · 1 of its ownK130487 Fastresponder Sternal Intraosseous DevicePyng Medical Corp. · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K970380F.a.S.T. 1 Intraosseous Infusion SystemPyng Medical Corp. · 1997 · cites it directly7descendants
- K072487FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008 · 2 generations on4descendants
- K080865FAST1 Intraosseous Infusion SystemPyng Medical Corp. · 2008 · 3 generations on3descendants
- K100124Fastx Sternal Intraosseous DevicePyng Medical Corp. · 2010 · 4 generations on2descendants
- K130487Fastresponder Sternal Intraosseous DevicePyng Medical Corp. · 2013 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883014 | Modified Intended Use of Monoject Bone Marrow Need | Sherwood Medical Co. | 1988 | — |
| +1 | K970380 | F.a.S.T. 1 Intraosseous Infusion System | Pyng Medical Corp. | 1997 | — |
| +2 | K072487 | FAST1 Intraosseous Infusion System | Pyng Medical Corp. | 2008 | — |
| +3 | K080865 | FAST1 Intraosseous Infusion System | Pyng Medical Corp. | 2008 | — |
| +4 | K100124 | Fastx Sternal Intraosseous Device | Pyng Medical Corp. | 2010 | 1 |
| +4 | K130487 | Fastresponder Sternal Intraosseous Device | Pyng Medical Corp. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 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.
Planning a device in GAA? 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? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970380 | F.a.S.T. 1 Intraosseous Infusion System | 1997 | 7 |
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, K970380 (Pyng Medical Corp., 1997) has gone furthest, with 7 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/K883014 · printed Nov 6, 2026
Cite this page
510(k) Report. “K883014: Modified Intended Use of Monoject Bone Marrow Need.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883014
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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