510(k) · Cleared
ClearedSterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perfect Medical Industry (Vn) Co., Ltd. · FMF Syringe, Piston
Cleared on Jun 12, 2024 as substantially equivalent to K211329 (Jiangsu Kangbao Medical Equipment Co., Ltd., 2021) after a 266-day review. Its family tree reaches back 9 generations to 1977. 1 later device descends from it.
- Decided
- Jun 12, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K771205 (1977). 20 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 5 generations between
- 3 generations backK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- 2 generations backK193526 Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd · 2020
- 1 generation backK211329 Sterile Disposable Syringe with Saftey Needle, Sterile Disposable…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2021
- This deviceK232950 Sterile Disposable Syringe, Sterile Disposable Syringe with needle…Perfect Medical Industry (Vn) Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK251089 EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL…Exelint International, Co. · 2025
Show all 9 generations
- Root · 9 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 8 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 7 generations backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- 6 generations backK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- 5 generations backK063613 Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006
- 4 generations backK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009
- 3 generations backK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- 2 generations backK193526 Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd · 2020
- 1 generation backK211329 Sterile Disposable Syringe with Saftey Needle, Sterile Disposable…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2021
- This deviceK232950 Sterile Disposable Syringe, Sterile Disposable Syringe with needle…Perfect Medical Industry (Vn) Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K251089EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe…Exelint International, Co. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −8 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −7 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| −6 | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| −5 | K063613 | Modification to Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2006 | — |
| −4 | K083514 | Terumo Syringe with/Without Needle | Terumo Europe N.V. | 2009 | — |
| −3 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Yangzhou Medline Industry, Co., Ltd. | 2017 | — |
| −2 | K193526 | Syringe with safety needle, Safety needle | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| −1 | K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with… | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2021 | — |
| 0 (this device) | K232950 | Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile… | Perfect Medical Industry (Vn) Co., Ltd. | 2024 | — |
| +1 | K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable… | Exelint International, Co. | 2025 | — |
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 |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle…Summary page 5…1 K232950 II Predicate Devices 510k Number K211329 Trade Name of Device: Sterile Disposable Syringe with Safety Needle, S… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe… | 2025 | 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 47 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K251089 (Exelint International, Co., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K211329.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Sterile Disposable Syringe is intended to be used to withdraw solutions and insert solutions into patient’s body. Sterile Disposable Syringe with needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient’s body. Sterile Disposable Syringe with safety needle is intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient’s body. 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 needlestick.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232950 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232950: Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232950
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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