510(k) · Cleared
ClearedSterile Single-use Syringe with Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangxi Hongda Medical Equipment Group, Ltd. · FMF Syringe, Piston
Cleared on Mar 20, 2017 as substantially equivalent to K072739 (Shandong Weigao Group Medical Polymer Co., Ltd., 2008) after a 130-day review. Its family tree reaches back 4 generations to 1993. 9 later devices descend from it.
- Decided
- Mar 20, 2017
- Review
- 130 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K931367 (1993). 20 ancestors in all, the oldest K822083 (1982). 9 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 3 generations backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- 2 generations backK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- 1 generation backK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
- This deviceK163161 Sterile Single-use Syringe with NeedleJiangxi Hongda Medical Equipment Group, Ltd. · 2017
- Descendant · cites it directly · 5 of its ownK200242 StaClear SyringeTribofilm Research, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK243936 StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear…Staclear, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK251849 StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear…Staclear, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243027 Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50…Hangzhou Sightnovo Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK243149 Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter…Congruence Medical Solutions, LLC · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K200242StaClear SyringeTribofilm Research, Inc. · 2020 · cites it directly5descendants
- K243936StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc. · 2025 · 2 generations on1descendant
- K251849StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Staclear, Inc. · 2025 · 3 generations on0descendants
- K243027Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27…Hangzhou Sightnovo Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K243149Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)Congruence Medical Solutions, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −3 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| −2 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| −1 | K072739 | Jierui Syringes and Needles | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008 | — |
| 0 (this device) | K163161 | Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group, Ltd. | 2017 | — |
| +1 | K200242 | StaClear Syringe | Tribofilm Research, Inc. | 2020 | — |
| +2 | K243936 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe… | Staclear, Inc. | 2025 | — |
| +3 | K251849 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe… | Staclear, Inc. | 2025 | — |
| +2 | K243027 | Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC… | Hangzhou Sightnovo Medical Technology Co., Ltd. | 2025 | — |
| +2 | K243149 | Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) | Congruence Medical Solutions, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K072739 | Jierui Syringes and NeedlesSummary page 5…Subsequent Product Code: FMI Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital 5. Identification of Predicate Device 510(k) Number: K072739 Product Name: Sterile Hypodermic Syringe for single use, with/without needle Indications for Use; Sterile Single-use… | 2008 |
What descends from it? (9)
4 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 24 years and passes through 5 companies; a new generation was cleared every 9.0 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K200242 (Tribofilm Research, Inc., 2020) has gone furthest, with 5 descendants of its own.
- 10 other devices also cite its predicate K072739.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Sterile Single-use Syringe with Needle is intended to inject fluids into or withdraw fluids from the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163161: Sterile Single-use Syringe with Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163161
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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