510(k) · Cleared
ClearedNipro Disposable Syringe with or Without Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corp. · FMF Syringe, Piston
Cleared on Aug 26, 2005 as substantially equivalent to K944355 (Nissho Corp., 1994) and 1 other predicate after a 73-day review. Its family tree reaches back 2 generations to 1994. 10 later devices descend from it.
- Decided
- Aug 26, 2005
- Review
- 73 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944355 (1994). 10 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
- 1 generation backK030683 Nipro Disposable SyringesNipro Medical Corp. · 2003
- This deviceK051574 Nipro Disposable Syringe with or Without NeedleNipro Medical Corp. · 2005
- Descendant · cites it directly · 8 of its ownK063280 Injekt SyringeB.Braun Medical, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 3 of its ownK101547 Henke- Sass, Wolf Piston Syringe (Norm-Jet)Henke-Sass, Wolf GmbH · 2010
- Descendant · cites it directly · 3 of its ownK071459 B. Braun Piston Syringes and Omnican and Omnifix Insulin SyringesB.Braun Medical, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 2 of its ownK202432 MiniLoad SyringeOcuject, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK241385 Omnifix Syringe NRFitB.Braun Medical, Inc. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K063280Injekt SyringeB.Braun Medical, Inc. · 2006 · cites it directly8descendants
- K101547Henke- Sass, Wolf Piston Syringe (Norm-Jet)Henke-Sass, Wolf GmbH · 2010 · 2 generations on3descendants
- K071459B. Braun Piston Syringes and Omnican and Omnifix Insulin SyringesB.Braun Medical, Inc. · 2007 · cites it directly3descendants
- K202432MiniLoad SyringeOcuject, LLC · 2021 · 3 generations on2descendants
- K241385Omnifix Syringe NRFitB.Braun Medical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944355 | Nipro Branded Disposable Syringes, Needles | Nissho Corp. | 1994 | — |
| −1 | K030683 | Nipro Disposable Syringes | Nipro Medical Corp. | 2003 | — |
| 0 (this device) | K051574 | Nipro Disposable Syringe with or Without Needle | Nipro Medical Corp. | 2005 | — |
| +1 | K063280 | Injekt Syringe | B.Braun Medical, Inc. | 2006 | 2 |
| +2 | K101547 | Henke- Sass, Wolf Piston Syringe (Norm-Jet) | Henke-Sass, Wolf GmbH | 2010 | — |
| +1 | K071459 | B. Braun Piston Syringes and Omnican and Omnifix Insulin Syringes | B.Braun Medical, Inc. | 2007 | 2 |
| +3 | K202432 | MiniLoad Syringe | Ocuject, LLC | 2021 | — |
| +2 | K241385 | Omnifix Syringe NRFit | B.Braun Medical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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 16.1 · 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K944355 | Nipro Branded Disposable Syringes, NeedlesSummary page 1…Single Lumen Needle (880.5570) 807.92 (a)(3) Legally Marketed Substantially Equivalent Device: Nipro Branded Disposable Syringes (K944355 and K030683) 807.92 (a)(4) Description of Device: The subject devices can be classified… | 1994 |
| * | K030683 | Nipro Disposable SyringesSummary page 1…Needle (880.5570) 807.92 (a)(3) Legally Marketed Substantially Equivalent Device: Nipro Branded Disposable Syringes (K944355 and K030683) 807.92 (a)(4) Description of Device: The subject devices can be classified as piston s… | 2003 |
What descends from it? (10)
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 8.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K063280 (B.Braun Medical, Inc., 2006) has gone furthest, with 8 descendants of its own.
- 5 other devices also cite its predicate K944355.
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) | — |
What is it indicated for?
The Disposable Hypodermic Syringes and Needles are intended for use to inject fluids into or withdraw fluids from the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051574 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051574: Nipro Disposable Syringe with or Without Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051574
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026