510(k) · Cleared
ClearedDisposable Pen Injector (KXYC-03C02, KXYC-03A03)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Enjosim Medical Technology Co., Ltd. · FMF Syringe, Piston
Cleared on Aug 14, 2026 as substantially equivalent to K240961 (Wuxi Nest Biotechnology Co., Ltd., 2024) after a 262-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Aug 14, 2026
- Review
- 262 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010359 (2001). No later device cites it as a predicate yet.
- Root · 6 generations backK010359 InnovoNovo Nordisk A/S · 2001
- 5 generations backK123766 Novopen Echo, a Dial a Dose Insulin Delivery PenNovo Nordisk, Inc. · 2013 · Recalled
- 4 generations backK150874 NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)Novo Nordisk, Inc. · 2015 · Recalled
- 3 generations backK162602 NovoPen EchoNovo Nordisk, Inc. · 2016 · Recalled
- 2 generations backK182387 NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)Novo Nordisk, Inc. · 2018
- 1 generation backK240961 Disposable Pen Injector AssemblyWuxi Nest Biotechnology Co., Ltd. · 2024
- This deviceK253747 Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010359 | Innovo | Novo Nordisk A/S | 2001 | — |
| −5 | K123766 | Novopen Echo, a Dial a Dose Insulin Delivery Pen | Novo Nordisk, Inc. | 2013 | 1 |
| −4 | K150874 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | Novo Nordisk, Inc. | 2015 | 1 |
| −3 | K162602 | NovoPen Echo | Novo Nordisk, Inc. | 2016 | 1 |
| −2 | K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | Novo Nordisk, Inc. | 2018 | — |
| −1 | K240961 | Disposable Pen Injector Assembly | Wuxi Nest Biotechnology Co., Ltd. | 2024 | — |
| 0 (this device) | K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K240961 | Disposable Pen Injector AssemblySummary page 5…lation Number: 21 CFR 880.5860 Regulatory Class: Class II Product Code: FMF Review Panel: General Hospital III. Predicate Device Primary predicate device 510(k) Number: K240961 Trade Name: Disposable Pen Injector Assembly IV. Device Description The Disposable Pen Injector is a disposable single-patient u… | 2024 |
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 25 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 6 ancestors have a recall of any class.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Disposable Pen Injector is a disposable pen injector designed for single patient use by diabetics for the subcutaneous self-injection of a desired dose insulin. The disposable pen injector uses 3mL cartridge of HUMALOG (U-100, insulin lispro for injection) and a single use detachable and disposable insulin pen needle (supplied separately). The pen injector allows the user to dial the desired dose up to 80 units in 1-unit increments. It is intended for general population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253747: Disposable Pen Injector (KXYC-03C02, KXYC-03A03).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253747
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026