510(k) · Cleared
ClearedTerumo SURGUARD3 Safety Needle & Hypodermic Syringe with Safety Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo (Philippines) Corporation · FMI Needle, Hypodermic, Single Lumen
Cleared on Aug 28, 2012 as substantially equivalent to K113422 (Terumo (Philippines) Corporation, 2012) after a 32-day review. Its family tree reaches back 6 generations to 1990. 4 later devices descend from it.
- Decided
- Aug 28, 2012
- Review
- 32 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K904198 (1990). 11 ancestors in all, the oldest K771205 (1977). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 5 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 4 generations backK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
- 3 generations backK040531 Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004
- 2 generations backK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005
- 1 generation backK113422 Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe…Terumo (Philippines) Corporation · 2012
- This deviceK122249 Terumo SURGUARD3 Safety Needle & Hypodermic Syringe with Safety NeedleTerumo (Philippines) Corporation · 2012
- Descendant · cites it directly · 1 of its ownK212095 SurGuard3 Safety Hypodermic NeedleTerumo Europe N.V. · 2022
- Descendant · cites it directly · 1 of its ownK152362 Terumo SurGuard 3 Safety Hypodermic NeedleTerumo (Philippines) Corporation · 2015
- Descendant · 2 generations on · 0 of its ownK260933 Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R…Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251447 K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)Terumo Europe N.V. · 2025
Most influential descendants
Showing 4 of 4 · See all- K212095SurGuard3 Safety Hypodermic NeedleTerumo Europe N.V. · 2022 · cites it directly1descendant
- K152362Terumo SurGuard 3 Safety Hypodermic NeedleTerumo (Philippines) Corporation · 2015 · cites it directly1descendant
- K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2026 · 2 generations on0descendants
- K251447K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)Terumo Europe N.V. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −5 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| −4 | K031453 | Terumo Surguard 2 Safety Needle | Terumo Medical Corp. | 2003 | — |
| −3 | K040531 | Terumo SURGUARD2 Safety Needle | Terumo Medical Corp. | 2004 | — |
| −2 | K051865 | Terumo Surguard 2 Safety Needle or Similar | Terumo Medical Corp. | 2005 | — |
| −1 | K113422 | Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with… | Terumo (Philippines) Corporation | 2012 | — |
| 0 (this device) | K122249 | Terumo SURGUARD3 Safety Needle & Hypodermic Syringe with Safety Needle | Terumo (Philippines) Corporation | 2012 | — |
| +1 | K212095 | SurGuard3 Safety Hypodermic Needle | Terumo Europe N.V. | 2022 | — |
| +1 | K152362 | Terumo SurGuard 3 Safety Hypodermic Needle | Terumo (Philippines) Corporation | 2015 | — |
| +2 | K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R… | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026 | — |
| +2 | K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 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 |
|---|---|---|---|
| * | K113422 | Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety NeedleSummary page 4…materials for the Terumo Surouard®3 Safety Hypodermic Needle and with attached syringe are the same as the materials of the SurGuard3 as submitted in the 510(k), K113422. The I cc/mi syringe plunger is made up of polystyrene, while the 3, 5, and 10 cc/mI syringes utilize polypropylene for the p… | 2012 |
What descends from it? (4)
2 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 22 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K212095 (Terumo Europe N.V., 2022) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K113422.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The TERUMO® SurGuard®3 Safety Needle device is intended for use in the aspiration and injection of fluids for medical purposes. The TERUMO SurGuard®3 Safety Needle is compatible for use with standard luer slip and luer lock syringes.
Additionally, after withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122249: Terumo SURGUARD3 Safety Needle & Hypodermic Syringe with Safety Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122249
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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