510(k) · Cleared
ClearedNipro Branded Disposable Syringes, Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nissho Corp. · FMF Syringe, Piston
Cleared on Dec 7, 1994 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 43 later devices descend from it.
- Decided
- Dec 7, 1994
- Review
- 91 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 0
43 later devices descend from it, 6 citing it directly.
- This deviceK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
- Descendant · cites it directly · 23 of its ownK030683 Nipro Disposable SyringesNipro Medical Corp. · 2003
- Descendant · cites it directly · 13 of its ownK052474 Nipro Hypodermic NeedleNipro Medical Corp. · 2005
- Descendant · 2 generations on · 12 of its ownK102584 Imc Hypodermic NeedleInternational Medsurg Connection · 2011 · Recalled
- Descendant · cites it directly · 10 of its ownK051574 Nipro Disposable Syringe with or Without NeedleNipro Medical Corp. · 2005
- Descendant · 2 generations on · 9 of its ownK061194 Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210…Smiths Medical Asd, Inc. · 2006
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K030683Nipro Disposable SyringesNipro Medical Corp. · 2003 · cites it directly23descendants
- K052474Nipro Hypodermic NeedleNipro Medical Corp. · 2005 · cites it directly13descendants
- K102584Imc Hypodermic NeedleInternational Medsurg Connection · 2011 · 2 generations on12descendants
- K051574Nipro Disposable Syringe with or Without NeedleNipro Medical Corp. · 2005 · cites it directly10descendants
- K061194Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558Smiths Medical Asd, Inc. · 2006 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944355 | Nipro Branded Disposable Syringes, Needles | Nissho Corp. | 1994 | — |
| +1 | K030683 | Nipro Disposable Syringes | Nipro Medical Corp. | 2003 | — |
| +1 | K052474 | Nipro Hypodermic Needle | Nipro Medical Corp. | 2005 | — |
| +2 | K102584 | Imc Hypodermic Needle | International Medsurg Connection | 2011 | 20 |
| +1 | K051574 | Nipro Disposable Syringe with or Without Needle | Nipro Medical Corp. | 2005 | — |
| +2 | K061194 | Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510… | Smiths Medical Asd, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 8 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? (43)
See all 436 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, K030683 (Nipro Medical Corp., 2003) has gone furthest, with 23 descendants of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
https://510kreport.com/device/K944355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K944355: Nipro Branded Disposable Syringes, Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944355
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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