510(k) · Cleared
ClearedSterile Hypodermic Syringes for Single Use with Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sichuan Prius Biotechnology Co., Ltd. · FMF Syringe, Piston
Cleared on Oct 4, 2022 as substantially equivalent to K211329 (Jiangsu Kangbao Medical Equipment Co., Ltd., 2021) after a 175-day review. Its family tree reaches back 9 generations to 1977.
- Decided
- Oct 4, 2022
- Review
- 175 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K771205 (1977). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 5 generations between
- 3 generations backK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- 2 generations backK193526 Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd · 2020
- 1 generation backK211329 Sterile Disposable Syringe with Saftey Needle, Sterile Disposable…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2021
- This deviceK221068 Sterile Hypodermic Syringes for Single Use with NeedlesSichuan Prius Biotechnology Co., Ltd. · 2022
Show all 9 generations
- Root · 9 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 8 generations backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- 7 generations backK023271 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2002
- 6 generations backK052034 Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2005
- 5 generations backK063613 Modification to Terumo Syringe with/Without NeedleTerumo Medical Corp. · 2006
- 4 generations backK083514 Terumo Syringe with/Without NeedleTerumo Europe N.V. · 2009
- 3 generations backK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
- 2 generations backK193526 Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd · 2020
- 1 generation backK211329 Sterile Disposable Syringe with Saftey Needle, Sterile Disposable…Jiangsu Kangbao Medical Equipment Co., Ltd. · 2021
- This deviceK221068 Sterile Hypodermic Syringes for Single Use with NeedlesSichuan Prius Biotechnology Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −8 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| −7 | K023271 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2002 | — |
| −6 | K052034 | Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2005 | — |
| −5 | K063613 | Modification to Terumo Syringe with/Without Needle | Terumo Medical Corp. | 2006 | — |
| −4 | K083514 | Terumo Syringe with/Without Needle | Terumo Europe N.V. | 2009 | — |
| −3 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Yangzhou Medline Industry, Co., Ltd. | 2017 | — |
| −2 | K193526 | Syringe with safety needle, Safety needle | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| −1 | K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with… | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2021 | — |
| 0 (this device) | K221068 | Sterile Hypodermic Syringes for Single Use with Needles | Sichuan Prius Biotechnology Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle…Summary page 5…: FMI; Regulation Number: 21CFR 880.5570; Review Panel: General Hospital; 5. Identification of Predicate Device Predicate Device 510(k) Number: K211329 Product Name: Sterile Disposable Syringes with Needles 6. Device Description The Sterile Hypodermic Syringes for… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 20 ancestors have a recall of any class.
- 1 other device also cites its predicate K211329.
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 Hypodermic Syringes for Single Use with Needles is intended for use in the aspiration and injection of fluids for medical purpose.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221068 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221068: Sterile Hypodermic Syringes for Single Use with Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221068
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