510(k) · Cleared
ClearedMedline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · FMF Syringe, Piston
Cleared on Dec 9, 2022 as substantially equivalent to K193526 (Jiangsu Caina Medical Co.,Ltd, 2020) and 1 other predicate after a 443-day review. Its family tree reaches back 8 generations to 1977.
- Decided
- Dec 9, 2022
- Review
- 443 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K771205 (1977). 21 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK213054 Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeMedline Industries, Inc. · 2022
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) | K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe | Medline Industries, Inc. | 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 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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? (2)
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 4…men Needle) - MEG (Antistick Syringe) Predicate Device Primary Predicate Device: Syringe with Safety Needle, Safety Needle (K193526). Secondary Predicate Device: BD Eclipse Hypodermic Needle (K161170). Medline Industries, LP.… | 2020 |
| * | K161170 | BD Eclipse Hypodermic NeedleSummary page 4…stick Syringe) Predicate Device Primary Predicate Device: Syringe with Safety Needle, Safety Needle (K193526). Secondary Predicate Device: BD Eclipse Hypodermic Needle (K161170). Medline Industries, LP. Three Lakes Drive Northfield, IL 600… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 45 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 21 ancestors have a recall of any class.
- 3 other devices also cite its predicate K193526.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Medline Sure-Snap Safety Syringe is intended for use in the aspiration and injection of fluids for medical purposes. 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 Medline Sure-Snap Safety Needle is intended for use with a luer-lock syringe for aspiration and injection of fluids for medical purposes. 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/K213054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213054: Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213054
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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