510(k) · Cleared
ClearedTerumo Surguard 2 Safety Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jul 8, 2003 as substantially equivalent to K923127 (Concord/Portex, 1993) and 3 other predicates after a 62-day review. Its family tree reaches back 2 generations to 1990. 74 later devices descend from it.
- Decided
- Jul 8, 2003
- Review
- 62 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K904198 (1990). 5 ancestors in all, the oldest K771203 (1977). 74 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 1 generation backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- This deviceK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
- Descendant · cites it directly · 67 of its ownK040531 Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004
- Descendant · cites it directly · 65 of its ownK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005
- Descendant · 2 generations on · 60 of its ownK113422 Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe…Terumo (Philippines) Corporation · 2012
- 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
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K040531Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004 · cites it directly67descendants
- K051865Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005 · cites it directly65descendants
- K113422Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety NeedleTerumo (Philippines) Corporation · 2012 · 2 generations on60descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −1 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| 0 (this device) | K031453 | Terumo Surguard 2 Safety Needle | Terumo Medical Corp. | 2003 | — |
| +1 | K040531 | Terumo SURGUARD2 Safety Needle | Terumo Medical Corp. | 2004 | — |
| +1 | K051865 | Terumo Surguard 2 Safety Needle or Similar | Terumo Medical Corp. | 2005 | — |
| +2 | K113422 | Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with… | Terumo (Philippines) Corporation | 2012 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 7 | 0 |
| 2022 | 19 | 0 |
| 2023 | 7 | 0 |
| 2024 | 8 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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? (4)
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 |
|---|---|---|---|
| * | K923127 | Needle-Pro CartridgeSummary page 2…0 18 1). D. Substantial Equivalence The SurGuard 2’” Safety Needle without or with syringe attached is substantially equivalent to: 1. K923127 - SurGuard Needle/Syringe with Needle Protection device manufactured by Portex, Inc. 2. K771203… | 1993 |
| * | K771203 | Disp. Hypodermic NeedleSummary page 2…substantially equivalent to: 1. K923127 - SurGuard Needle/Syringe with Needle Protection device manufactured by Portex, Inc. 2. K771203 - Terumo Hypodermic Needle 3. K771205 & K980181 - Terumo Hypodermic Syringe All of these cleared devices serve… | 1977 |
| * | K771205 | Hypodermic SyringeSummary page 2…Sakty Needle will be individually packaged and sterilized as a safety needle only or as a safety needle with attached Terumo syringe (as cleared under K77 1205 and K980 18 1). D. Substantial Equivalence The SurGuard 2’” Safety Needle without or with syringe attac… | 1977 |
| * | K980181 | Terumo Disposable Hypodermc SyringeSummary page 2…will be individually packaged and sterilized as a safety needle only or as a safety needle with attached Terumo syringe (as cleared under K77 1205 and K980 18 1). D. Substantial Equivalence The SurGuard 2’” Safety Needle without or with syringe attached is substan… | 1998 |
What descends from it? (74)
See all 744 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040531 | Terumo SURGUARD2 Safety Needle | 2004 | 67 |
| K051865 | Terumo Surguard 2 Safety Needle or Similar | 2005 | 65 |
| K063450 | Portex Hypodermic Needle- Pro Edge Safety Device, 18GX1, 401810, 19GX1, 401910… | 2007 | 8 |
| K071785 | Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with… | 2007 | 7 |
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 13 years and passes through 2 companies; a new generation was cleared every 10.2 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K040531 (Terumo Medical Corp., 2004) has gone furthest, with 67 descendants of its own.
- 2 other devices also cite its predicate K923127.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 TERUMOB SurGuard 2TMSAFETY NEEDLE device is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Needle is compatible for use with standard luer slip and luer lock syringes.
Additionally, after withdraw 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/K031453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031453: Terumo Surguard 2 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/K031453
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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