510(k) · Cleared
ClearedSafety Hypodermic Needles with/Without Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuxi Yushou Medical Applicances Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Nov 20, 2013 as substantially equivalent to K113422 (Terumo (Philippines) Corporation, 2012) and 1 other predicate after a 295-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Nov 20, 2013
- Review
- 295 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K904198 (1990). 13 ancestors in all, the oldest K771205 (1977). No later device cites it as a predicate yet.
- 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 deviceK130212 Safety Hypodermic Needles with/Without SyringeWuxi Yushou Medical Applicances Co., Ltd. · 2013
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) | K130212 | Safety Hypodermic Needles with/Without Syringe | Wuxi Yushou Medical Applicances Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 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? (2)
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 1…edle 3. Predicate Devices Information: Safety Hypodermic Needle WithAAithout Syringe. Trade Name: TERUMO@ SurGuard®&3 Safety Needle 510(K) Number: K113422 Trade Name: BD Single Use, Hypodermic Syringe (PMN-5lO(K) SUBMISSION] COMPANlY PROPRIETARY AND CONFIDENIAL… | 2012 |
| * | K110771 | BD Single Use, Hypodermic SyringeSummary page 2…[PMN20120023 [Safe Hypodermic Needles WithVvhout Syringe] Rev 0.00 01101113 510(K) Number: K1 10771 4. Devices Description: Safety Hypodermic Needle With/Without Syringe The Safety Hypodermic Needle With/Without Syringe… | 2011 |
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?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 13 ancestors have a recall of any class.
- 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. 2013, 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 Safety Hypodermic Needle With/Without Syringe device is intended for use in the aspiration and injection of fluids for medical purposes. The Safety Hypodermic Needle With/Without Syringe 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 needle-stick.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130212: Safety Hypodermic Needles with/Without Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130212
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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