510(k) · Cleared
ClearedTerumo Syringe with/Without Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · FMF Syringe, Piston
Cleared on Aug 16, 2005 as substantially equivalent to K023271 (Terumo Medical Corp., 2002) after a 19-day review. Its family tree reaches back 3 generations to 1977. 39 later devices descend from it.
- Decided
- Aug 16, 2005
- Review
- 19 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K771205 (1977). 39 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 2 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 1 generation backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- This deviceK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- Descendant · cites it directly · 36 of its ownK063613 Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006
- Descendant · cites it directly · 34 of its ownK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009
- Descendant · 2 generations on · 32 of its ownK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- Descendant · 3 generations on · 14 of its ownK192551 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently…Jiangsu Caina Medical Co.,Ltd · 2020
- Descendant · 3 generations on · 7 of its ownK193526 Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd · 2020
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K063613Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006 · cites it directly36descendants
- K083514Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009 · cites it directly34descendants
- K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…Yangzhou Medline Industry, Co., Ltd. · 2017 · 2 generations on32descendants
- K1925511ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety…Jiangsu Caina Medical Co.,Ltd · 2020 · 3 generations on14descendants
- K193526Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd · 2020 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −2 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −1 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| 0 (this device) | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| +1 | K063613 | Modification to Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2006 | — |
| +1 | K083514 | Terumo Syringe with/Without Needle | Terumo Europe N.V. | 2009 | — |
| +2 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Yangzhou Medline Industry, Co., Ltd. | 2017 | — |
| +3 | K192551 | 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle… | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| +3 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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 |
|---|---|---|---|
| * | K023271 | Terumo Syringe with/Without NeedleSummary page 1…al purposes to inj.1ect fluids into or withdraw fluids fromn the body. Note: This is the samne intended use as the predicate device, Terurno Syringe with/without needle (K02327 1). Device Description The I iml Teruino Syringe with/without Needle consists of 3 mnain parts or 4 parts, i.e., a barrel, Pluinge… | 2002 |
What descends from it? (39)
See all 393 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 28 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K063613 (Terumo Medical Corp., 2006) has gone furthest, with 36 descendants of its own.
- 3 other devices also cite its predicate K023271.
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 with/without needle is intended to be used for medical purposes to
inject fluids into or withdraw fluids from the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052034: Terumo 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/K052034
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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