510(k) · Cleared
ClearedSafety Needle Sheath, Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Concord/Portex · FMI Needle, Hypodermic, Single Lumen
Cleared on May 3, 1991 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 3, 1991
- Review
- 63 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK911037 Safety Needle Sheath, ModificationConcord/Portex · 1991
- Descendant · cites it directly · 2 of its ownK012736 Monoject Safety NeedleTyco Healthcare · 2001 · Recalled
- Descendant · 2 generations on · 0 of its ownK253110 Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK082908 Novaguard, Model 3611001West Pharmaceutical Services, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK073188 Hypodermic Needle-Pro Edge Safety DeviceSmiths Medical Asd, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK013006 Ovus Capless Safety NeedleOvus Systems · 2002
Most influential descendants
Showing 5 of 5 · See all- K012736Monoject Safety NeedleTyco Healthcare · 2001 · cites it directly2descendants
- K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026 · 2 generations on0descendants
- K082908Novaguard, Model 3611001West Pharmaceutical Services, Inc. · 2009 · 2 generations on0descendants
- K073188Hypodermic Needle-Pro Edge Safety DeviceSmiths Medical Asd, Inc. · 2008 · cites it directly0descendants
- K013006Ovus Capless Safety NeedleOvus Systems · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911037 | Safety Needle Sheath, Modification | Concord/Portex | 1991 | — |
| +1 | K012736 | Monoject Safety Needle | Tyco Healthcare | 2001 | 93 |
| +2 | K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | 2026 | — |
| +2 | K082908 | Novaguard, Model 3611001 | West Pharmaceutical Services, Inc. | 2009 | — |
| +1 | K073188 | Hypodermic Needle-Pro Edge Safety Device | Smiths Medical Asd, Inc. | 2008 | — |
| +1 | K013006 | Ovus Capless Safety Needle | Ovus Systems | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 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.
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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 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, K012736 (Tyco Healthcare, 2001) has gone furthest, with 2 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/K911037 · printed Nov 5, 2026
Cite this page
510(k) Report. “K911037: Safety Needle Sheath, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K911037
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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