510(k) · Cleared
ClearedAmsure Disposable Syringe with/Without Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amsino International, Inc. · FMF Syringe, Piston
Cleared on Jun 29, 2006 as substantially equivalent to K945715 (Sherwood Medical Co., 1995) and 1 other predicate after a 76-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jun 29, 2006
- Review
- 76 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K944355 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
- 2 generations backK030683 Nipro Disposable SyringesNipro Medical Corp. · 2003
- 1 generation backK051574 Nipro Disposable Syringe with or Without NeedleNipro Medical Corp. · 2005
- This deviceK061039 Amsure Disposable Syringe with/Without NeedleAmsino International, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944355 | Nipro Branded Disposable Syringes, Needles | Nissho Corp. | 1994 | — |
| −2 | K030683 | Nipro Disposable Syringes | Nipro Medical Corp. | 2003 | — |
| −1 | K051574 | Nipro Disposable Syringe with or Without Needle | Nipro Medical Corp. | 2005 | — |
| 0 (this device) | K061039 | Amsure Disposable Syringe with/Without Needle | Amsino International, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 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 |
|---|---|---|---|
| * | K945715 | Monoject (R) Piston Syringes; 3,6,12,20,35 and 60CC SizesSummary page 1…EME and FM! Medical Specialty: General Hospital Device Class: Class II Predicate Devices: Monoject®~Piston Syringes (K9457 15) Nipro"' Disposable ]Hypodenmic Syringes with or withoul. Needle (KO5 1574) Device Description: Th… | 1995 |
| * | K051574 | Nipro Disposable Syringe with or Without Needle | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
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 AMSURE® Disposable Syringe with/without Needle is intended for the injection of fluids into, or the withdrawal of fluids from parts of the body below the skin. Needles are intended to mate with male nozzles of piston syringes or administration sets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061039: Amsure Disposable Syringe with/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/K061039
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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