510(k) · Cleared
ClearedJierui Syringes and Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shandong Weigao Group Medical Polymer Co., Ltd. · MEG Syringe, Antistick
Cleared on Mar 21, 2008 as substantially equivalent to K070936 (Welmed, Inc., 2007) and 3 other predicates after a 176-day review. Its family tree reaches back 3 generations to 1993. 78 later devices descend from it.
- Decided
- Mar 21, 2008
- Review
- 176 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K931367 (1993). 19 ancestors in all, the oldest K822083 (1982). 78 later devices descend from it, 11 citing it directly.
- Root · 3 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 2 generations backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- 1 generation backK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- This deviceK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
- Descendant · cites it directly · 36 of its ownK110421 Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011
- Descendant · cites it directly · 31 of its ownK112057 KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011
- Descendant · 2 generations on · 13 of its ownK190002 Sterile Hypodermic Syringe for Single use, with/without needle…Shanghai Kohope Medical Devices Co., Ltd. · 2019
- Descendant · cites it directly · 12 of its ownK180417 Self-destruction Safety Syringes for Single Use; Sterile Hypodermic…Berpu Medical Technology Co., Ltd. · 2018
- Descendant · cites it directly · 9 of its ownK163161 Sterile Single-use Syringe with NeedleJiangxi Hongda Medical Equipment Group, Ltd. · 2017
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K110421Disposable Insulin SyringeWenzhou Wuzhou Import & Export Co., Ltd. · 2011 · cites it directly36descendants
- K112057KDL Syringes and NeedleShanghai Kindly Enterprise Dev. Group Co., · 2011 · cites it directly31descendants
- K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe…Shanghai Kohope Medical Devices Co., Ltd. · 2019 · 2 generations on13descendants
- K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single…Berpu Medical Technology Co., Ltd. · 2018 · cites it directly12descendants
- K163161Sterile Single-use Syringe with NeedleJiangxi Hongda Medical Equipment Group, Ltd. · 2017 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −2 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| −1 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| 0 (this device) | 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 | — |
| +1 | K112057 | KDL Syringes and Needle | Shanghai Kindly Enterprise Dev. Group Co., | 2011 | — |
| +2 | K190002 | Sterile Hypodermic Syringe for Single use, with/without needle, Sterile… | Shanghai Kohope Medical Devices Co., Ltd. | 2019 | — |
| +1 | K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes… | Berpu Medical Technology Co., Ltd. | 2018 | — |
| +1 | K163161 | Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group, Ltd. | 2017 | — |
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 |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 13 | 0 |
| 2022 | 13 | 0 |
| 2023 | 15 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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 MEG? 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 MEG device
- #1 K192551 1ml Luer Slip or Luer Lock Syringe, Syringe…score 19.6 · 7 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 2…-64264467 x 152 Fax: +86-21-64264468 x 809 Email: Diana.hong~mid-link.net Eric.chen~mid-link.net 3. Predicate Device a. K number: K070936 Trade Name: Welmed Hypodermic Syringe (various sizes) Common Name: Syringes, Hypodermic Cl… | 2007 |
| * | K071630 | Terumo 31G Thinpro Insulin SyringeSummary page 2…nge (various sizes) Common Name: Syringes, Hypodermic Classification Name: Piston Syringe Product Code: FMF b. K number: K071630 Trade Name: TERUMO 3 1G ThinPro Insulin Syringe Classification Name: Piston syringe with fixed hypodermic… | 2007 |
| * | K053519 | Safety SyringeSummary page 2…1G ThinPro Insulin Syringe Classification Name: Piston syringe with fixed hypodermic single lumen needle Product Code: FMF c. K number: K053519 Trade Name: Safety Syringe Common Name: Syringe Classification Name: Syringe,Antistick… | 2006 |
| * | K070440 | BD Hypoint NeedleSummary page 2…Trade Name: Safety Syringe Common Name: Syringe Classification Name: Syringe,Antistick Product Code: MEG d. K number: K070440 Trade Name: BD Hypoint Common Name: Hypodermic Needle Classification Name: Single Lumen Hypod… | 2007 |
What descends from it? (78)
See all 7811 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110421 | Disposable Insulin Syringe | 2011 | 36 |
| K112057 | KDL Syringes and Needle | 2011 | 31 |
| K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single… | 2018 | 12 |
| K163161 | Sterile Single-use Syringe with Needle | 2017 | 9 |
| K151949 | Disposable Insulin Syringe | 2015 | 6 |
| K162180 | Disposable Insulin Syringe | 2016 | 5 |
| K210991 | Disposable Sterile Syringe, Disposable Sterile Syringe with Needle | 2021 | 0 |
| K172938 | Disposable Sterile Needle | 2018 | 0 |
| K163162 | Sterile Hypodermic Safety Syringes for Single Use | 2017 | 0 |
| K124037 | Jung Rim Single Use Hypodermic Syringe with Needle | 2013 | 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 15 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K110421 (Wenzhou Wuzhou Import & Export Co., Ltd., 2011) has gone furthest, with 36 descendants of its own.
- 4 other devices also cite its predicate K070936.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MEG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEG
229in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEG
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MEG
148in 2025
MAUDE reports naming product code MEG, 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 | 8 | 100 | 0 | 21 |
| 2008 | 4 | 145 | 1 | 20 |
| 2009 | 2 | — | 0 | 26 |
| 2010 | 2 | — | 1 | 34 |
| 2011 | 5 | 113 | 0 | 34 |
| 2012 | 5 | 109 | 0 | 22 |
| 2013 | 1 | — | 5 | 27 |
| 2014 | 5 | 153 | 0 | 36 |
| 2015 | 7 | 253 | 1 | 51 |
| 2016 | 3 | 179 | 0 | 94 |
| 2017 | 3 | 130 | 0 | 181 |
| 2018 | 1 | — | 0 | 269 |
| 2019 | 4 | 249 | 0 | 497 |
| 2020 | 4 | 296 | 0 | 353 |
| 2021 | 5 | 152 | 0 | 541 |
| 2022 | 13 | 216 | 0 | 170 |
| 2023 | 5 | 229 | 0 | 120 |
| 2024 | 0 | — | 1 (1) | 112 |
| 2025 | 1 | — | 0 | 148 |
| 2026 | 1 | — | 0 | — |
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 Retractable Auto-Disable Syringe for single use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of…
Read the full statement (136 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 Retractable Auto-Disable Syringe for single use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.
The sterile Insulin Syringe for single use with fixed needle 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/K072739 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072739: Jierui Syringes and Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072739
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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