510(k) · Cleared
ClearedDMC Medical Single-Use Polycarbonate Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dmc Medical, Ltd. · FMF Syringe, Piston
Cleared on Jun 10, 2011 as substantially equivalent to K070856 (Icu Medical, Inc., 2007) after a 170-day review. Its family tree reaches back 3 generations to 1998. 4 later devices descend from it.
- Decided
- Jun 10, 2011
- Review
- 170 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- 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 backK070856 Icu Medical Single-Use SyringeIcu Medical, Inc. · 2007
- This deviceK103736 DMC Medical Single-Use Polycarbonate SyringeDmc Medical, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK171131 MHC Standard and NRFit Tip SyringesMazza Healthcare, LLC · 2017
- Descendant · cites it directly · 0 of its ownK223678 Sterile Syringes for Single UseShanghai Kindly Enterprise Development Group Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK212764 Medwell Technology Ltd Syringes, various sizesMedwell Technology, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK161812 Freedom SyringeProcedure Products, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K171131MHC Standard and NRFit Tip SyringesMazza Healthcare, LLC · 2017 · cites it directly1descendant
- K223678Sterile Syringes for Single UseShanghai Kindly Enterprise Development Group Co., Ltd. · 2023 · cites it directly0descendants
- K212764Medwell Technology Ltd Syringes, various sizesMedwell Technology, Ltd. · 2022 · 2 generations on0descendants
- K161812Freedom SyringeProcedure Products, Inc. · 2017 · 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 | K070856 | Icu Medical Single-Use Syringe | Icu Medical, Inc. | 2007 | — |
| 0 (this device) | K103736 | DMC Medical Single-Use Polycarbonate Syringe | Dmc Medical, Ltd. | 2011 | — |
| +1 | K171131 | MHC Standard and NRFit Tip Syringes | Mazza Healthcare, LLC | 2017 | — |
| +1 | K223678 | Sterile Syringes for Single Use | Shanghai Kindly Enterprise Development Group Co., Ltd. | 2023 | — |
| +2 | K212764 | Medwell Technology Ltd Syringes, various sizes | Medwell Technology, Ltd. | 2022 | — |
| +1 | K161812 | Freedom Syringe | Procedure Products, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K070856 | Icu Medical Single-Use SyringeSummary page 1…e, Hypodermic Classification Name: Piston Syringe, 21 CFR 880.5860, Class II Device, Product Code: FMF Legally Marketed Predicate Devices for Substantial Equivalence: *K 070856 - ICU Medical Single-Use Syringe Rationale for SE: The ICU Medical Single-Use Syringe is a Class Il device that is offered pre-… | 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)
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 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K171131 (Mazza Healthcare, LLC, 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K070856.
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?
DMC Medical piston type syringes are single use syringes intended for injecting fluids into or withdrawing fluids from the body.
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/K103736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103736: DMC Medical Single-Use Polycarbonate Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103736
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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