510(k) · Cleared
ClearedJung Rim Single Use Hypodermic Syringe with Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jung Rim Medical Industrial Co., Ltd. · FMF Syringe, Piston
Cleared on Sep 12, 2013 as substantially equivalent to K113091 (Jiangyin Caina Technology Co., Ltd., 2011) and 1 other predicate after a 258-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Sep 12, 2013
- Review
- 258 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K931367 (1993). 21 ancestors in all, the oldest K822083 (1982). No later device cites it as a predicate yet.
- Root · 4 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 3 generations backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- 2 generations backK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- 1 generation backK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
- This deviceK124037 Jung Rim Single Use Hypodermic Syringe with NeedleJung Rim Medical Industrial Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −3 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| −2 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| −1 | K072739 | Jierui Syringes and Needles | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008 | — |
| 0 (this device) | K124037 | Jung Rim Single Use Hypodermic Syringe with Needle | Jung Rim Medical Industrial Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K113091 | Syringes, With or without NeedlesSummary page 4…Ltd. Polymer Products Co.. 1-TD 5l10(k) Number NEW K113091 K072739 Classifi- Class 11 Class!… | 2011 |
| * | K072739 | Jierui Syringes and NeedlesSummary page 2…0.5860 2) Proposed Device Name: Needles *Classification: Class 11 Product Code: FMI Regulation Numiber: 21 CFR 880.5570 b) K number: K072739 - Manufacturer: ShanDong WeiGao Group Medical Polymer Products Co.. LTD 1) Proposed Device Name: Sterile Hypodermi… | 2008 |
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 20 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
- 3 of the 21 ancestors have a recall of any class.
- 2 other devices also cite its predicate K113091.
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?
Jung Rim single use hypodermic syringe with Needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124037: Jung Rim Single Use Hypodermic 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/K124037
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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