510(k) · Cleared
ClearedTerumo Retractable Needle (RN) Syringe
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 May 21, 1996 as substantially equivalent to K771205 (Terumo America, Inc., 1977) and 2 other predicates after a 274-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- May 21, 1996
- Review
- 274 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K771205 (1977). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- This deviceK953940 Terumo Retractable Needle (RN) SyringeTerumo Medical Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| 0 (this device) | K953940 | Terumo Retractable Needle (RN) Syringe | Terumo Medical Corp. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1994 | 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 16.2 · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K771205 | Hypodermic SyringeSummary page 1…ctable Needle (RN) Syringe Predicate Product:(s): There are two products referenced as predicates for the Terumo RN Syringe: - Terumo Hypodermic Syringes with Needles, K771205 and K771203. - U.S. Medical Instruments SafeSnap™ syringe, K925039. Description of the Subject Device: The Terumo RN Syringe is… | 1977 |
| * | K771203 | Disp. Hypodermic NeedleSummary page 1…e (RN) Syringe Predicate Product:(s): There are two products referenced as predicates for the Terumo RN Syringe: - Terumo Hypodermic Syringes with Needles, K771205 and K771203. - U.S. Medical Instruments SafeSnap™ syringe, K925039. Description of the Subject Device: The Terumo RN Syringe is a sterile, s… | 1977 |
| * | K925039 | Safesnap Safety SyringeSummary page 1…oducts referenced as predicates for the Terumo RN Syringe: - Terumo Hypodermic Syringes with Needles, K771205 and K771203. - U.S. Medical Instruments SafeSnap™ syringe, K925039. Description of the Subject Device: The Terumo RN Syringe is a sterile, single use device designed to be similar to present sing… | 1994 |
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?
- 1 of the 3 ancestors has a recall of any class.
- 5 other devices also cite its predicate K771205.
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 intended use of the Terumo Medical Corporation (Terumo) RN Syringe is to inject fluids into, or withdraw fluids from, the body below the surface of the skin for medical purposes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K953940 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953940: Terumo Retractable Needle (RN) Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953940
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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