510(k) · Cleared
ClearedKDL Syringes and Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Kindly Enterprise Dev. Group Co., · FMF Syringe, Piston
Cleared on Dec 14, 2011 as substantially equivalent to K070936 (Welmed, Inc., 2007) and 3 other predicates after a 148-day review. Its family tree reaches back 5 generations to 1993. 31 later devices descend from it.
- Decided
- Dec 14, 2011
- Review
- 148 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K931367 (1993). 21 ancestors in all, the oldest K822083 (1982). 31 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 4 generations backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- 3 generations backK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- 2 generations backK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
- 1 generation backK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
- This deviceK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011
- Descendant · cites it directly · 13 of its ownK190002 Sterile Hypodermic Syringe for Single use, with/without needle…Shanghai Kohope Medical Devices Co., Ltd. · 2019
- Descendant · cites it directly · 5 of its ownK153537 Sol-M Insulin Syringe, Sol-M TB SyringeSol-Millennium Medical, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK170218 Vesco Medical NRFit Tip SyringesVesco Medical, LLC · 2017
- Descendant · 2 generations on · 3 of its ownK211242 Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic…Promisemed Hangzhou Meditech Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK212635 SofjecHwajin Medical Co., Ltd. · 2023
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe…Shanghai Kohope Medical Devices Co., Ltd. · 2019 · cites it directly13descendants
- K153537Sol-M Insulin Syringe, Sol-M TB SyringeSol-Millennium Medical, Inc. · 2016 · cites it directly5descendants
- K170218Vesco Medical NRFit Tip SyringesVesco Medical, LLC · 2017 · cites it directly4descendants
- K211242Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic SyringesPromisemed Hangzhou Meditech Co., Ltd. · 2021 · 2 generations on3descendants
- K212635SofjecHwajin Medical Co., Ltd. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −4 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| −3 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| −2 | K072739 | Jierui Syringes and Needles | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008 | — |
| −1 | K110421 | Disposable Insulin Syringe | Wenzhou Wuzhou Import & Export Co., Ltd. | 2011 | — |
| 0 (this device) | K112057 | KDL Syringes and Needle | Shanghai Kindly Enterprise Dev. Group Co., | 2011 | — |
| +1 | K190002 | Sterile Hypodermic Syringe for Single use, with/without needle, Sterile… | Shanghai Kohope Medical Devices Co., Ltd. | 2019 | — |
| +1 | K153537 | Sol-M Insulin Syringe, Sol-M TB Syringe | Sol-Millennium Medical, Inc. | 2016 | — |
| +1 | K170218 | Vesco Medical NRFit Tip Syringes | Vesco Medical, LLC | 2017 | — |
| +2 | K211242 | Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| +2 | K212635 | Sofjec | Hwajin Medical Co., Ltd. | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K070936 | Welmed Hypodermic SyringeSummary page 5…mic Syringe for single use, with needle, is determined to be Substantially Eqtuivalent (SE) to the predicate device. Welmed Hypodermic Syringe (various sizes), K070936. in respect of safety and effectiveness. The proposed device, Sterile Hypodermic Syringe for single use, without needle, i… | 2007 |
| * | K072739 | Jierui Syringes and NeedlesSummary page 2…cation a. 510(k) Number: K(070936 Product Name: Welmed Hypodermic Syringe (various sizes) Manufacturer: Welmed Inc. b. 510(k) Number: K072739. Product Name: Sterile Hypodermic Syringe for Single Use, without Needle Manuflacturer: Shandong Weigao Group… | 2008 |
| * | K110421 | Disposable Insulin SyringeSummary page 2…Sterile Hypodermic Syringe for Single Use, without Needle Manuflacturer: Shandong Weigao Group Medical Polymer Products Co.. Ltd. c. 510(k) Number: KI 110421 Product Name: Disposable Insulin Syringe Manufacturer: Wenzhou Wuzhou Import & Export Co., Ltd. d. 510… | 2011 |
| * | K070440 | BD Hypoint NeedleSummary page 2…. 510(k) Number: KI 110421 Product Name: Disposable Insulin Syringe Manufacturer: Wenzhou Wuzhou Import & Export Co., Ltd. d. 510(k) Number: K070440 Product Name: BD Hypoint Manufacturer: BD Medical-Pharmaceutical Systems… | 2007 |
What descends from it? (31)
See all 316 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190002 | Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe… | 2019 | 13 |
| K153537 | Sol-M Insulin Syringe, Sol-M TB Syringe | 2016 | 5 |
| K170218 | Vesco Medical NRFit Tip Syringes | 2017 | 4 |
| K210227 | Sterile syringe for single use with/without needle | 2021 | 2 |
| K211211 | Sterile syringes for single use with/without needle | 2021 | 1 |
| K231729 | Sterile syringes for single use with/without needle | 2023 | 0 |
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 18 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K190002 (Shanghai Kohope Medical Devices Co., Ltd., 2019) has gone furthest, with 13 descendants of its own.
- 4 other devices also cite its predicate K070936.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 sterile hypodermic syringe for single use With/Without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The sterile insulin syringe for single use with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The sterile insulin syringe for…
Read the full statement (137 words)
The sterile hypodermic syringe for single use With/Without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
The sterile insulin syringe for single use with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The sterile insulin syringe for single use with needle, with the calibration unit of insulin for U-40, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The sterile hypodermic needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112057: KDL Syringes 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/K112057
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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