510(k) · Cleared
ClearedTerumo Syringe for Administration of UV Sensitive Medicines
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Europe N.V. · FMF Syringe, Piston
Cleared on Apr 6, 2006 as substantially equivalent to K980181 (Terumo Medical Corp., 1998) after a 120-day review. Its family tree reaches back 2 generations to 1977. 36 later devices descend from it.
- Decided
- Apr 6, 2006
- Review
- 120 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K771205 (1977). 36 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 1 generation backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- This deviceK053413 Terumo Syringe for Administration of UV Sensitive MedicinesTerumo Europe N.V. · 2006
- Descendant · cites it directly · 35 of its ownK070264 50 ML Terumo Syringe for Administration of UV Sensitive Medicines…Terumo Europe N.V. · 2007
- Descendant · 2 generations on · 34 of its ownK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009
- Descendant · 3 generations on · 32 of its ownK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- Descendant · 4 generations on · 14 of its ownK192551 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently…Jiangsu Caina Medical Co.,Ltd · 2020
- Descendant · 4 generations on · 7 of its ownK193526 Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd · 2020
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K07026450 ML Terumo Syringe for Administration of UV Sensitive Medicines, Model BS-50LBTerumo Europe N.V. · 2007 · cites it directly35descendants
- K083514Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009 · 2 generations on34descendants
- K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…Yangzhou Medline Industry, Co., Ltd. · 2017 · 3 generations on32descendants
- K1925511ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety…Jiangsu Caina Medical Co.,Ltd · 2020 · 4 generations on14descendants
- K193526Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd · 2020 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −1 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| 0 (this device) | K053413 | Terumo Syringe for Administration of UV Sensitive Medicines | Terumo Europe N.V. | 2006 | — |
| +1 | K070264 | 50 ML Terumo Syringe for Administration of UV Sensitive Medicines, Model BS-50LB | Terumo Europe N.V. | 2007 | — |
| +2 | K083514 | Terumo Syringe with/Without Needle | Terumo Europe N.V. | 2009 | — |
| +3 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Yangzhou Medline Industry, Co., Ltd. | 2017 | — |
| +4 | K192551 | 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle… | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| +4 | K193526 | Syringe with safety needle, Safety needle | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 11 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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? (1)
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 |
|---|---|---|---|
| * | K980181 | Terumo Disposable Hypodermc SyringeSummary page 2…peration, materials and performance to the cleared "Terumo Disposable Hypodermic Syringe", manufactured by Terumo Medical Corporation in which is the subject ofK980181, with the exception that the opaque colored Terumo Syringe manufactured by Terumo Europe N.V. additionally allows the a… | 1998 |
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070264 | 50 ML Terumo Syringe for Administration of UV Sensitive Medicines, Model BS-50LB | 2007 | 35 |
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 29 years and passes through 3 companies; a new generation was cleared every 20.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K070264 (Terumo Europe N.V., 2007) has gone furthest, with 35 descendants of its own.
- 5 other devices also cite its predicate K980181.
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 Terumo Syringe for administration of UV sensitive medicines is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling. The opaque color of the barrel allows the administration of UV sensitive medicines,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053413 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053413: Terumo Syringe for Administration of UV Sensitive Medicines.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053413
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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