510(k) · Cleared
ClearedSyringe with safety needle, Safety needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Caina Medical Co.,Ltd · FMF Syringe, Piston
Cleared on Jul 17, 2020 as substantially equivalent to K170651 (Yangzhou Medline Industry, Co., Ltd., 2017) after a 211-day review. Its family tree reaches back 7 generations to 1977. 7 later devices descend from it.
- Decided
- Jul 17, 2020
- Review
- 211 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K771205 (1977). 18 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 6 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 5 generations backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- 4 generations backK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- 3 generations backK063613 Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006
- 2 generations backK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009
- 1 generation backK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- This deviceK193526 Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd · 2020
- Descendant · cites it directly · 3 of its ownK211329 Sterile Disposable Syringe with Saftey Needle, Sterile Disposable…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK232950 Sterile Disposable Syringe, Sterile Disposable Syringe with needle…Perfect Medical Industry (Vn) Co., Ltd. · 2024
- Descendant · 3 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 ownK213054 Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeMedline Industries, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK221073 Sterile Hypodermic Syringes for Single Use with Safety NeedlesSichuan Prius Biotechnology Co., Ltd. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K211329Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2021 · cites it directly3descendants
- K232950Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable…Perfect Medical Industry (Vn) Co., Ltd. · 2024 · 2 generations on1descendant
- K251089EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe…Exelint International, Co. · 2025 · 3 generations on0descendants
- K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeMedline Industries, Inc. · 2022 · cites it directly0descendants
- K221073Sterile Hypodermic Syringes for Single Use with Safety 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 |
|---|---|---|---|---|---|
| −7 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −6 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −5 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| −4 | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| −3 | K063613 | Modification to Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2006 | — |
| −2 | K083514 | Terumo Syringe with/Without Needle | Terumo Europe N.V. | 2009 | — |
| −1 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Yangzhou Medline Industry, Co., Ltd. | 2017 | — |
| 0 (this device) | 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 | — |
| +2 | K232950 | Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile… | Perfect Medical Industry (Vn) Co., Ltd. | 2024 | — |
| +3 | K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable… | Exelint International, Co. | 2025 | — |
| +1 | K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe | Medline Industries, Inc. | 2022 | — |
| +1 | K221073 | Sterile Hypodermic Syringes for Single Use with Safety 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 |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 3 | 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 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 |
|---|---|---|---|
| * | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…Summary page 6…60; Review Panel: General Hospital 5. Identification of Predicate Device and Reference Device Predicate Device Information: 510(k) Number: K170651 Product Name: Sterile Disposable Syringe with Safety Needle (used as predicate device) Sterile Di… | 2017 |
| † | K161170 | BD Eclipse Hypodermic Needle | 2016 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle… | 2021 | 3 |
| K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe | 2022 | 0 |
| K221073 | Sterile Hypodermic Syringes for Single Use with Safety Needles | 2022 | 0 |
| K211753 | Sterile Syringe With Safety Needle | 2021 | 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 43 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K211329 (Jiangsu Kangbao Medical Equipment Co., Ltd., 2021) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K170651.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 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 stick.
The Safety Needle is intended for use with a 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 stick.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193526 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193526: Syringe with safety needle, 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/K193526
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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