510(k) · Cleared
ClearedSterile Hypodermic Syringe and Needle for Single Use, Sterile Insuling Syringe for Single Use with Fixed Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Double Dove Industrial Co., Ltd. · FMF Syringe, Piston
Cleared on Jun 12, 2009 as substantially equivalent to K980987 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) and 2 other predicates after a 71-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Jun 12, 2009
- Review
- 71 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K931367 (1993). 15 ancestors in all, the oldest K822083 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 2 generations backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- 1 generation backK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- This deviceK090929 Sterile Hypodermic Syringe and Needle for Single Use, Sterile…Shanghai Double Dove Industrial Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK110697 Tiger Syringes and NeedlesTiger Medical Products, Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K110697Tiger Syringes and NeedlesTiger Medical Products, Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −2 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| −1 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| 0 (this device) | K090929 | Sterile Hypodermic Syringe and Needle for Single Use, Sterile Insuling Syringe… | Shanghai Double Dove Industrial Co., Ltd. | 2009 | — |
| +1 | K110697 | Tiger Syringes and Needles | Tiger Medical Products, Ltd. | 2011 | — |
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 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K980987 | Becton Dickinson SyringeSummary page 2…(2) Regulation Number: 880.5570 (3) Product Code: FMI (4) Class: II (5) Review Panel: General Hospital 5. Predicate Device Identification: a. K number: K980987 Trade Name: Becton Dickinson Single Use Hypodermic Syringes b. K number: K071630 Trade Name: TERUMO 31 G ThinPro Insu… | 1998 |
| * | K071630 | Terumo 31G Thinpro Insulin SyringeSummary page 2…iew Panel: General Hospital 5. Predicate Device Identification: a. K number: K980987 Trade Name: Becton Dickinson Single Use Hypodermic Syringes b. K number: K071630 Trade Name: TERUMO 31 G ThinPro Insulin Syringe c. K number: K070440 Trade Name: BD Hypoint… | 2007 |
| * | K070440 | BD Hypoint NeedleSummary page 2…r: K980987 Trade Name: Becton Dickinson Single Use Hypodermic Syringes b. K number: K071630 Trade Name: TERUMO 31 G ThinPro Insulin Syringe c. K number: K070440 Trade Name: BD Hypoint 2… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110697 | Tiger Syringes and Needles | 2011 | 0 |
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 16 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K110697 (Tiger Medical Products, Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 17 other devices also cite its predicate K980987.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Sterile Hypodermic Syringe for Single Use is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. Their function is mechanical.
The sterile Insulin Syringe for single use with fixed needle is a device is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin, and for the injection of insulin into parts of the body below the surface skin.
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090929: Sterile Hypodermic Syringe and Needle for Single Use, Sterile Insuling Syringe for Single Use with Fixed Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090929
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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