510(k) · Cleared
ClearedSterile Hypodermic Syringes for Single Use
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 K180417 (Berpu Medical Technology Co., Ltd., 2018) after a 175-day review. Its family tree reaches back 7 generations to 1990. 1 later device descends from it.
- Decided
- Oct 4, 2022
- Review
- 175 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K904198 (1990). 32 ancestors in all, the oldest K771205 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 6 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 5 generations backK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
- 4 generations backK040531 Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004
- 3 generations backK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005
- 2 generations backK113422 Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe…Terumo (Philippines) Corporation · 2012
- 1 generation backK180417 Self-destruction Safety Syringes for Single Use; Sterile Hypodermic…Berpu Medical Technology Co., Ltd. · 2018
- This deviceK221079 Sterile Hypodermic Syringes for Single UseSichuan Prius Biotechnology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK242099 Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe…Sol-Millennium Medical, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without NeedleSol-Millennium Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −6 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| −5 | K031453 | Terumo Surguard 2 Safety Needle | Terumo Medical Corp. | 2003 | — |
| −4 | K040531 | Terumo SURGUARD2 Safety Needle | Terumo Medical Corp. | 2004 | — |
| −3 | K051865 | Terumo Surguard 2 Safety Needle or Similar | Terumo Medical Corp. | 2005 | — |
| −2 | K113422 | Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with… | Terumo (Philippines) Corporation | 2012 | — |
| −1 | K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes… | Berpu Medical Technology Co., Ltd. | 2018 | — |
| 0 (this device) | K221079 | Sterile Hypodermic Syringes for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022 | — |
| +1 | K242099 | Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without… | Sol-Millennium Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
| 1982 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 16.2 · 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 |
|---|---|---|---|
| * | K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single…Summary page 5…II; Product Code: FMF; Regulation Number: 21CFR 880.5860; Review Panel: General Hospital; 5. Identification of Predicate Device 510(k) Number: K180417 Product Name: Sterile Hypodermic Syringes for Single Use 6. Device Description The Sterile Disposable Syringe is… | 2018 |
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 |
|---|---|---|---|
| K242099 | Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle | 2024 | 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 32 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 6 of the 32 ancestors have a recall of any class.
- Of its descendants, K242099 (Sol-Millennium Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K180417.
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 are intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221079 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221079: Sterile Hypodermic Syringes for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221079
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