510(k) · Cleared
ClearedModification to Terumo 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 Dec 26, 2006 as substantially equivalent to K023271 (Terumo Medical Corp., 2002) and 1 other predicate after a 21-day review. Its family tree reaches back 4 generations to 1977. 36 later devices descend from it.
- Decided
- Dec 26, 2006
- Review
- 21 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K771205 (1977). 36 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 3 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 2 generations backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- 1 generation backK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- This deviceK063613 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
- Descendant · 4 generations on · 6 of its ownK210443 PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- 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
- K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −3 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −2 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| −1 | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| 0 (this device) | 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 | — |
| +4 | K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | Poonglim Pharmatech, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023271 | Terumo Syringe with/Without NeedleSummary page 1…es to inject fluids into or withdraw fluids from the body. Note: This is the same intended use as the predicate device, Terumo Syringe with/without needle cleared under K023271 and K051864. Device Description The Terumo 30 and 60cc/mL Syringes consist of 3 main parts, a barrel, plunger, and gasket. Barre… | 2002 |
| Kept off the family tree | K051864 | FDA’s K051864 is Magstim RAPID2, Magstim Super RAPID2, Models 3004-000, 3005-00 Our reading of the summary gave K051864, FDA’s number for Magstim RAPID2, Magstim Super RAPID2, Models 3004-000… (The Magstim Company, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Terumo Syringe with/without needle”. Kept off the family tree. Summary page 1…fluids into or withdraw fluids from the body. Note: This is the same intended use as the predicate device, Terumo Syringe with/without needle cleared under K023271 and K051864. Device Description The Terumo 30 and 60cc/mL Syringes consist of 3 main parts, a barrel, plunger, and gasket. Barrel is made fr… | 2005 |
| * | K052034 | Terumo Syringe with/Without NeedleSummary page 1…L Terumo Syringes without needle are substantially equivalent to the materials used in the predicate Terumo Syringe with/without needle devices cleared under K023271 and K052034. Specifications PRODUCT DESCRIPTION 30cc/mI luer slip syringe 3Occ/ml luer lock syringe… | 2005 |
What descends from it? (36)
See all 362 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 29 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K083514 (Terumo Europe N.V., 2009) has gone furthest, with 34 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/K063613 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063613: Modification to Terumo Syringe with/Without Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063613
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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