510(k) · Cleared
ClearedWTF Secura Syringe and Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Wantefu Medical Apparatus Co., Ltd. · FMF Syringe, Piston
Cleared on Dec 12, 2013 as substantially equivalent to K023752 (Bd, 2003) after a 156-day review. Its family tree reaches back 2 generations to 1998. 5 later devices descend from it.
- Decided
- Dec 12, 2013
- Review
- 156 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980069 (1998). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK980069 Vanishpoint SyringeRetractable Technologies, Inc. · 1998
- 1 generation backK023752 BD Integra SyringeBd · 2003 · Recalled
- This deviceK132120 WTF Secura Syringe and NeedleBeijing Wantefu Medical Apparatus Co., Ltd. · 2013
- Descendant · cites it directly · 3 of its ownK143497 Safety Auto-Disable Syrine with Needle (Auto-Lock)Guangdong Intmed Medical Appliance Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK231727 Sterile Auto-Disable Syringes with/without Needle for Single UseWepon Medical Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK221981 SafeR Syringe and SafeR StingRoncadelle Operations Srl · 2022
- Descendant · 2 generations on · 0 of its ownK210229 Sterile Auto-Disable Syringes with/without Needle for Single UseZhejiang Kangkang Medical-Devices Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK211210 Sterile Auto-Disable Syringes with/without Needle for Single UseAzur Medical Company, Inc. · 2022
Most influential descendants
Showing 5 of 5 · See all- K143497Safety Auto-Disable Syrine with Needle (Auto-Lock)Guangdong Intmed Medical Appliance Co., Ltd. · 2015 · cites it directly3descendants
- K231727Sterile Auto-Disable Syringes with/without Needle for Single UseWepon Medical Technology Co., Ltd. · 2023 · 2 generations on0descendants
- K221981SafeR Syringe and SafeR StingRoncadelle Operations Srl · 2022 · cites it directly0descendants
- K210229Sterile Auto-Disable Syringes with/without Needle for Single UseZhejiang Kangkang Medical-Devices Co., Ltd. · 2022 · 2 generations on0descendants
- K211210Sterile Auto-Disable Syringes with/without Needle for Single UseAzur Medical Company, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980069 | Vanishpoint Syringe | Retractable Technologies, Inc. | 1998 | — |
| −1 | K023752 | BD Integra Syringe | Bd | 2003 | 2 |
| 0 (this device) | K132120 | WTF Secura Syringe and Needle | Beijing Wantefu Medical Apparatus Co., Ltd. | 2013 | — |
| +1 | K143497 | Safety Auto-Disable Syrine with Needle (Auto-Lock) | Guangdong Intmed Medical Appliance Co., Ltd. | 2015 | — |
| +2 | K231727 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Wepon Medical Technology Co., Ltd. | 2023 | — |
| +1 | K221981 | SafeR Syringe and SafeR Sting | Roncadelle Operations Srl | 2022 | — |
| +2 | K210229 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2022 | — |
| +2 | K211210 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Azur Medical Company, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 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 16.1 · 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? (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 |
|---|---|---|---|
| * | K023752 | BD Integra SyringeSummary page 2…ospital * Product Code: FMF, FMI, MEG * Regulation Number: 880.5560 " Device Class: 11 * Predicate Device Trade name: BID Integra 1ml Syringe K023752 * Predicate Device manufacturer: BD Medical Surgical 1 Becton Drive MC226 Franklin Lakes, NJ 4. Intended use: T… | 2003 |
What descends from it? (5)
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 15 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K143497 (Guangdong Intmed Medical Appliance Co., Ltd., 2015) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K023752.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 WTF Secure Syringe (with needle) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the suface of the skin.
The WTF Secure Syringe (with needle) has a manually attached WTP Secura Retracting Needle. The WiT Secure Syringe (with needle) contains an inner mechanism used to allow the WTF Secure Retracting Needle to be retracted inside the plunger rod of the syringe when opematoes thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132120: WTF Secura Syringe and Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132120
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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