510(k) · Cleared
Recalled · Class II · 2018Merit 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 31, 2018 as substantially equivalent to K070936 (Welmed, Inc., 2007) after a 71-day review. Its family tree reaches back 3 generations to 1998. 4 later devices descend from it. It has been recalled once.
- Decided
- Jan 31, 2018
- Review
- 71 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K980580 (1998). 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK980580 Becton Dickinson SyringesBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
- 2 generations backK024052 Merit Medical 1-ML SyringeMerit Medical Systems, Inc. · 2003
- 1 generation backK070936 Welmed Hypodermic SyringeWelmed, Inc. · 2007
- This deviceK173601 Merit SyringeMerit Medical Systems, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK191254 EndoClotEndoclot Plus Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK260997 Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01)Endoclot Plus Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK250853 Merit SyringeMerit Medical Systems, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK203738 QitexioMedex · 2022
Most influential descendants
Showing 4 of 4 · See all- K191254EndoClotEndoclot Plus Co., Ltd. · 2020 · cites it directly1descendant
- K260997Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01)Endoclot Plus Co., Ltd. · 2026 · 2 generations on0descendants
- K250853Merit SyringeMerit Medical Systems, Inc. · 2025 · cites it directly0descendants
- K203738QitexioMedex · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980580 | Becton Dickinson Syringes | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | — |
| −2 | K024052 | Merit Medical 1-ML Syringe | Merit Medical Systems, Inc. | 2003 | — |
| −1 | K070936 | Welmed Hypodermic Syringe | Welmed, Inc. | 2007 | — |
| 0 (this device) | K173601 | Merit Syringe | Merit Medical Systems, Inc. | 2018 | — |
| +1 | K191254 | EndoClot | Endoclot Plus Co., Ltd. | 2020 | — |
| +2 | K260997 | Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01) | Endoclot Plus Co., Ltd. | 2026 | — |
| +1 | K250853 | Merit Syringe | Merit Medical Systems, Inc. | 2025 | — |
| +1 | K203738 | Qitexio | Medex | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K070936 | Welmed Hypodermic SyringeSummary page 4…ulatory Class: 2 Device Product Code: FMF 21 CFR §: 880.5860 Premarket Notification: K070936 Manufacturer: Welmed, Inc. The Merit Syringe contains a calibrated hollow barrel… | 2007 |
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2018 | Class II | Z-2742-2018 | Nonconforming Material/Component | Supplier manufacturing defect with the syringe plunger tip. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K191254 (Endoclot Plus Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K070936.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Merit Syringe is used to inject fluids into, and withdraw fluids from, the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173601 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173601: Merit Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173601
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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