510(k) · Cleared
Recalled · Class II · 2021Vaclok Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · FMF Syringe, Piston
Cleared on Jan 5, 2000 after a 19-day review. The FDA summary names its predicate without a number. 1 of the 80 devices in its family, counting itself, has a Class I recall. 79 later devices descend from it. It has been recalled 11 times.
- Decided
- Jan 5, 2000
- Review
- 19 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 11
- Predicates
- 0
79 later devices descend from it, 4 citing it directly. 1 of the 80 devices in this family, counting this one, has a Class I recall.
- This deviceK994253 Vaclok SyringeMerit Medical Systems, Inc. · 2000
- Descendant · cites it directly · 63 of its ownK023272 Disposable Aspiration Needle NA-200HThe Olympus Optical Co. · 2002 · Recalled
- Descendant · cites it directly · 28 of its ownK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- Descendant · 2 generations on · 27 of its ownK100712 Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2010 · Recalled
- Descendant · 3 generations on · 26 of its ownK110030 Expect Endoscopic Aspiration NeedleBoston Scientific Corp · 2011 · Recalled
- Descendant · 3 generations on · 16 of its ownK112198 Expect Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2011
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193517 ViziShot 2 FLEX4 generations on · 2020
Most influential descendants
Showing 5 of 79 · See all- K023272Disposable Aspiration Needle NA-200HThe Olympus Optical Co. · 2002 · cites it directly63descendants
- K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · cites it directly28descendants
- K100712Resound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2010 · 2 generations on27descendants
- K110030Expect Endoscopic Aspiration NeedleBoston Scientific Corp · 2011 · 3 generations on26descendants
- K112198Expect Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation · 2011 · 3 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994253 | Vaclok Syringe | Merit Medical Systems, Inc. | 2000 | — |
| +1 | K023272 | Disposable Aspiration Needle NA-200H | The Olympus Optical Co. | 2002 | 1 |
| +1 | K050503 | Single Use Aspiration Needle NA-201SX-4022 | Olympus Medical Systems Corporation | 2005 | 5 |
| +2 | K100712 | Resound Endoscopic Ultrasound Aspiration Needle | Boston Scientific Corporation | 2010 | 5 |
| +3 | K110030 | Expect Endoscopic Aspiration Needle | Boston Scientific Corp | 2011 | 1 |
| +3 | K112198 | Expect Endoscopic Ultrasound Aspiration Needle | Boston Scientific Corporation | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 2017 | 9 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 1 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 7 | 0 |
| 2026 | 2 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | — | Merit Coronary Control Syringe Named without a submission number |
What descends from it? (79)
See all 794 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2021 | Class II | Z-0202-2022 | Under Investigation by firm | Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers. |
| Oct 22, 2010 | Not classified | Z-0504-2011 | Packaging process control | Packaging for syringes may have holes which would compromise the sterility of the package contents. |
| Oct 22, 2010 | Not classified | Z-0505-2011 | Packaging process control | Packaging for syringes may have holes which would compromise the sterility of the package contents. |
| Oct 22, 2010 | Not classified | Z-0506-2011 | Packaging process control | Packaging for syringes may have holes which would compromise the sterility of the package contents. |
| Oct 22, 2010 | Not classified | Z-0503-2011 | Packaging process control | Packaging for syringes may have holes which would compromise the sterility of the package contents. |
| Oct 2, 2003 | Not classified | Z-0308-04 | Other | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. |
| Oct 2, 2003 | Not classified | Z-0310-04 | Other | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. |
| Oct 2, 2003 | Not classified | Z-0307-04 | Other | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. |
| Oct 2, 2003 | Not classified | Z-0309-04 | Other | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. |
| Oct 2, 2003 | Not classified | Z-0311-04 | Other | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. |
| Oct 1, 2003 | Not classified | Z-0139-04 | Other | There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated… |
The 5 latest of 11 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K023272 (The Olympus Optical Co., 2002) has gone furthest, with 63 descendants of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 VACLOK Syringe is intended to be used by a cardiologist or radiologist during angiographic or radiologic procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994253: Vaclok Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994253
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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