510(k) · Cleared
ClearedMerit Medical 20 ML 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 Jun 24, 2011 as substantially equivalent to K024052 (Merit Medical Systems, Inc., 2003) after a 66-day review. Its family tree reaches back 2 generations to 1998. 4 later devices descend from it.
- Decided
- Jun 24, 2011
- Review
- 66 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980580 (1998). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK980580 Becton Dickinson SyringesBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
- 1 generation backK024052 Merit Medical 1-ML SyringeMerit Medical Systems, Inc. · 2003
- This deviceK111091 Merit Medical 20 ML SyringeMerit Medical Systems, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK152783 Merit 20 mL SyringeMerit Medical Systems, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK182216 Merit SyringeMerit Medical Systems, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK182279 Merit SyringeMerit Medical Systems, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK142636 Merit 10mL SyringeMerit Medical Systems, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K152783Merit 20 mL SyringeMerit Medical Systems, Inc. · 2015 · cites it directly2descendants
- K182216Merit SyringeMerit Medical Systems, Inc. · 2018 · 2 generations on0descendants
- K182279Merit SyringeMerit Medical Systems, Inc. · 2018 · 2 generations on0descendants
- K142636Merit 10mL SyringeMerit Medical Systems, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980580 | Becton Dickinson Syringes | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | — |
| −1 | K024052 | Merit Medical 1-ML Syringe | Merit Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K111091 | Merit Medical 20 ML Syringe | Merit Medical Systems, Inc. | 2011 | — |
| +1 | K152783 | Merit 20 mL Syringe | Merit Medical Systems, Inc. | 2015 | — |
| +2 | K182216 | Merit Syringe | Merit Medical Systems, Inc. | 2018 | — |
| +2 | K182279 | Merit Syringe | Merit Medical Systems, Inc. | 2018 | — |
| +1 | K142636 | Merit 10mL Syringe | Merit Medical Systems, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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.
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 |
|---|---|---|---|
| * | K024052 | Merit Medical 1-ML SyringeSummary page 1…Trade Name: Merit Medical 1-mL Syringe Predicate Classification Name: Syringe, Piston Device Premarket Notification: K024052 Manufacturer: Merit Medical Systems, Inc. Class 11 Classification 2… | 2003 |
What descends from it? (4)
2 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)
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 13 years and passes through 2 companies; a new generation was cleared every 8.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K152783 (Merit Medical Systems, Inc., 2015) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K024052.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Medical 20 ml Syringe is used to inject fluids into, or withdraw fluids from, the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111091: Merit Medical 20 ML Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111091
Report an extraction error
Are you the manufacturer?
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