510(k) · Cleared
ClearedEwnl Safety Syringe with Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiamei-Un Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Jun 3, 2014 as substantially equivalent to K022806 (M.K. Meditech Co., Ltd., 2002) and 1 other predicate after a 293-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Jun 3, 2014
- Review
- 293 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000572 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK000572 E.N.S.I. SyringeTri-Ject Intl. Corp. · 2000
- 3 generations backK020623 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 2 generations backK022806 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 1 generation backK034031 10 ML Bak'snap Duopross Retractable Safety SyringeM.K. Meditech Co., Ltd. · 2004
- This deviceK132557 Ewnl Safety Syringe with NeedleJiamei-Un Co., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000572 | E.N.S.I. Syringe | Tri-Ject Intl. Corp. | 2000 | — |
| −3 | K020623 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −2 | K022806 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −1 | K034031 | 10 ML Bak'snap Duopross Retractable Safety Syringe | M.K. Meditech Co., Ltd. | 2004 | — |
| 0 (this device) | K132557 | Ewnl Safety Syringe with Needle | Jiamei-Un Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K022806 | Duopro Safety Syringe (Duopross)Summary page 1…I/MEG D. Common name: Piston syringe E. Panel: General Hospital 3. Predicate device: * DuoProrm Safety Syringe, 3inL, 5mL (DuoProSS Tm ) (K022806) * Bak'Snap DuProSSm Retractable Safety Syringe, 1.0 mL(K03403 1) 4. Intended Use: EWNL TMSafety Syringe with Needle (IlmL… | 2002 |
| * | K034031 | 10 ML Bak'snap Duopross Retractable Safety SyringeSummary page 1…General Hospital 3. Predicate device: * DuoProrm Safety Syringe, 3inL, 5mL (DuoProSS Tm ) (K022806) * Bak'Snap DuProSSm Retractable Safety Syringe, 1.0 mL(K03403 1) 4. Intended Use: EWNL TMSafety Syringe with Needle (IlmL, 2 mL, 3 mL, 5 mL, and 10 mL) is a sterile, single-use, disposab… | 2004 |
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 14 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 5 ancestors has a recall.
- 5 other devices also cite its predicate K022806.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
EWNLTM Safety Syringe with Needle (1 mL, 2 mL, 3 mL, 5 mL, and 10 mL) is a sterile, single-use, disposable and non-reusable manual retractable safety syringe, intended for medical purposes for injection of fluids into the body, while reducing the risks of sharps injuries and the potential for syringe reuse. This syringe is intended to be used by nurse, clinicians, or professional healthcare providers only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132557: Ewnl Safety Syringe with Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132557
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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