510(k) · Cleared
ClearedSuresharp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gainor Medical U.S.A., Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Apr 14, 1995 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.
- Decided
- Apr 14, 1995
- Review
- 87 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK950159 SuresharpGainor Medical U.S.A., Inc. · 1995
- Descendant · cites it directly · 7 of its ownK973620 Vacuette Multi-Sample NeedleGreiner Meditech, Inc. · 1997
- Descendant · 2 generations on · 5 of its ownK061483 Vacuette Visio Plus Blood Collection NeedlesGreiner Bio-One North America, Inc. · 2006
- Descendant · 3 generations on · 1 of its ownK073127 Blood Collection Needle, Model 20G 21G 22GShandong Weigao Group Medical Polymer Co., Ltd. · 2007
- Descendant · 2 generations on · 1 of its ownK072320 Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 0 of its ownK233979 VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K973620Vacuette Multi-Sample NeedleGreiner Meditech, Inc. · 1997 · cites it directly7descendants
- K061483Vacuette Visio Plus Blood Collection NeedlesGreiner Bio-One North America, Inc. · 2006 · 2 generations on5descendants
- K073127Blood Collection Needle, Model 20G 21G 22GShandong Weigao Group Medical Polymer Co., Ltd. · 2007 · 3 generations on1descendant
- K072320Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc. · 2007 · 2 generations on1descendant
- K233979VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950159 | Suresharp | Gainor Medical U.S.A., Inc. | 1995 | — |
| +1 | K973620 | Vacuette Multi-Sample Needle | Greiner Meditech, Inc. | 1997 | — |
| +2 | K061483 | Vacuette Visio Plus Blood Collection Needles | Greiner Bio-One North America, Inc. | 2006 | — |
| +3 | K073127 | Blood Collection Needle, Model 20G 21G 22G | Shandong Weigao Group Medical Polymer Co., Ltd. | 2007 | — |
| +2 | K072320 | Greiner Vacuette Quickshield Complete | Greiner Bio-One North America, Inc. | 2007 | 1 |
| +3 | K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2011 | 2 | 0 |
| 2024 | 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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K973620 (Greiner Meditech, Inc., 1997) has gone furthest, with 7 descendants of its own.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
https://510kreport.com/device/K950159 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950159: Suresharp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950159
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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