510(k) · Cleared
ClearedSterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Kangbao Medical Equipment Co., Ltd. · MEG Syringe, Antistick
Cleared on Nov 15, 2021 as substantially equivalent to K193526 (Jiangsu Caina Medical Co.,Ltd, 2020) after a 196-day review. Its family tree reaches back 8 generations to 1977. 3 later devices descend from it.
- Decided
- Nov 15, 2021
- Review
- 196 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K771205 (1977). 19 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 7 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 6 generations backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- 5 generations backK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- 4 generations backK063613 Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006
- 3 generations backK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009
- 2 generations backK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- 1 generation backK193526 Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd · 2020
- This deviceK211329 Sterile Disposable Syringe with Saftey Needle, Sterile Disposable…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK232950 Sterile Disposable Syringe, Sterile Disposable Syringe with needle…Perfect Medical Industry (Vn) Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK251089 EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL…Exelint International, Co. · 2025
- Descendant · cites it directly · 0 of its ownK221068 Sterile Hypodermic Syringes for Single Use with NeedlesSichuan Prius Biotechnology Co., Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See all- K232950Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable…Perfect Medical Industry (Vn) Co., Ltd. · 2024 · cites it directly1descendant
- K251089EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe…Exelint International, Co. · 2025 · 2 generations on0descendants
- K221068Sterile Hypodermic Syringes for Single Use with NeedlesSichuan Prius Biotechnology Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −7 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −6 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| −5 | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| −4 | K063613 | Modification to Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2006 | — |
| −3 | K083514 | Terumo Syringe with/Without Needle | Terumo Europe N.V. | 2009 | — |
| −2 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Yangzhou Medline Industry, Co., Ltd. | 2017 | — |
| −1 | K193526 | Syringe with safety needle, Safety needle | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| 0 (this device) | K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with… | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2021 | — |
| +1 | K232950 | Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile… | Perfect Medical Industry (Vn) Co., Ltd. | 2024 | — |
| +2 | K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable… | Exelint International, Co. | 2025 | — |
| +1 | K221068 | Sterile Hypodermic Syringes for Single Use with Needles | Sichuan Prius Biotechnology Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K193526 | Syringe with safety needle, Safety needleSummary page 7…(k) Summary K211329 5. Identification of Predicate Device 510(k) Number: K193526 Product Name: Syringe with safety needle, Safety needle 6. Non-Clinical Test Conclusion… | 2020 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 44 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 19 ancestors have a recall of any class.
- Of its descendants, K232950 (Perfect Medical Industry (Vn) Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K193526.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Disposable Syringe with Safety Needle is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. The Sterile Disposable Syringe with Needle is intended for use in the aspiration and injection of fluids for medical purpose. The…
Read the full statement (189 words)
The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Disposable Syringe with Needle is intended for use in the aspiration and injection of fluids for medical purpose.
The Sterile Disposable Syringe is a sterile luer slip or luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Disposable Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211329: Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211329
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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