510(k) · Cleared
ClearedSterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shandong Weigao Group Medical Polymer Co., Ltd. · FMF Syringe, Piston
Cleared on Mar 11, 2022 as substantially equivalent to K170651 (Yangzhou Medline Industry, Co., Ltd., 2017) and 1 other predicate after a 178-day review. Its family tree reaches back 7 generations to 1977. 1 later device descends from it.
- Decided
- Mar 11, 2022
- Review
- 178 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K771205 (1977). 21 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 6 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 5 generations backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- 4 generations backK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- 3 generations backK063613 Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006
- 2 generations backK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009
- 1 generation backK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- This deviceK212920 Sterile Safety Syringe with Needle for Single Use, Sterile Safety…Shandong Weigao Group Medical Polymer Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK260514 Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle…CMT Health PTE., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead…CMT Health PTE., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −6 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −5 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| −4 | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| −3 | K063613 | Modification to Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2006 | — |
| −2 | K083514 | Terumo Syringe with/Without Needle | Terumo Europe N.V. | 2009 | — |
| −1 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Yangzhou Medline Industry, Co., Ltd. | 2017 | — |
| 0 (this device) | K212920 | Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic… | Shandong Weigao Group Medical Polymer Co., Ltd. | 2022 | — |
| +1 | K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™… | CMT Health PTE., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…Summary page 5…le Classification: II Product Code: FMI Regulation Number: 21 CFR 880.5570 5. Identification of Predicate Devices: 510(k) Number: K170651 Product Name: Sterile Disposable Syringe with Safety Needle (used as predicate device) Sterile Di… | 2017 |
| * | K201234 | BD SoloShot Mini Syringe/ BD Auto Disable SyringeSummary page 5…e Syringe Sterile Disposable Safety Needle (used as predicate device) Sterile Disposable Needle 510(k) Number: K201234 Product Name: BD SoloShot Mini Syringe/ BD Auto Disable Syringe Indications for Use: The Sterile Safety S… | 2020 |
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 |
|---|---|---|---|
| K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead… | 2026 | 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 45 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K260514 (CMT Health PTE., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K170651.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Safety Syringe with Needle for Single Use is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. The Sterile Safety Hypodermic Needle for Single Use is intended to be used with a luer slip or luer lock syringe for aspiration…
Read the full statement (130 words)
The Sterile Safety Syringe with Needle for Single Use is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
The Sterile Safety Hypodermic Needle for Single Use is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
The Sterile Auto-Disable Syringe with Needle for Single Use is intended for aspiration and injection of fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212920: Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212920
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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