510(k) · Cleared
Recalled · Class II · 2024Monoject 60ML Syringe (Luer Lock Tip, Luer Slip Tip, Catheter Tip)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nipro Medical Corporation · FMF Syringe, Piston
Cleared on Aug 28, 2013 as substantially equivalent to K980987 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) and 1 other predicate after an 85-day review. Its family tree reaches back 5 generations to 1977. It has been recalled once.
- Decided
- Aug 28, 2013
- Review
- 85 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K771205 (1977). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 4 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 3 generations backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- 2 generations backK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- 1 generation backK063613 Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006
- This deviceK131641 Monoject 60ML Syringe (Luer Lock Tip, Luer Slip Tip, Catheter Tip)Nipro Medical Corporation · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −4 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −3 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| −2 | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| −1 | K063613 | Modification to Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2006 | — |
| 0 (this device) | K131641 | Monoject 60ML Syringe (Luer Lock Tip, Luer Slip Tip, Catheter Tip) | Nipro Medical Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K980987 | Becton Dickinson SyringeSummary page 1…n Number: 21 CFR 880.5860 Panel: 80 Product Code: FMF 807.92(a)(3) Legally marketed substantial equivalent device: Becton Dickinson Syringes K980987 Terumo Syringe with/without Needle K063613 807.92(a)(4) Description of device: The Monoject 60mL Syringe is… | 1998 |
| * | K063613 | Modification to Terumo Syringe with/Without NeedleSummary page 1…Product Code: FMF 807.92(a)(3) Legally marketed substantial equivalent device: Becton Dickinson Syringes K980987 Terumo Syringe with/without Needle K063613 807.92(a)(4) Description of device: The Monoject 60mL Syringe is a standard piston syringe without needle. It cons… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2024 | Class II | Z-2039-2024 | Component change control | Quarantined product was inadvertently distributed |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 17 other devices also cite its predicate K980987.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 syringe is intended to inject or withdraw fluids from the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131641 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131641: Monoject 60ML Syringe (Luer Lock Tip, Luer Slip Tip, Catheter Tip).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131641
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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