510(k) · Cleared
ClearedHypodermic Syringes & Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifelong Meditech Private Limited · FMF Syringe, Piston
Cleared on Jul 18, 2023 as substantially equivalent to K060211 (Wenzhou Wuzhou Group Co., Ltd., 2006) and 1 other predicate after a 295-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jul 18, 2023
- Review
- 295 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K000572 (2000). 13 ancestors in all, the oldest K944355 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK000572 E.N.S.I. SyringeTri-Ject Intl. Corp. · 2000
- 5 generations backK020623 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 4 generations backK022806 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 3 generations backK031594 Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety…M.K. Meditech Co., Ltd. · 2003
- 2 generations backK042500 Duopross SyringesDuopross Meditech Corporation · 2005
- 1 generation backK060211 Wuzhou Syringe, with/Without NeedleWenzhou Wuzhou Group Co., Ltd. · 2006
- This deviceK222925 Hypodermic Syringes & NeedleLifelong Meditech Private Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000572 | E.N.S.I. Syringe | Tri-Ject Intl. Corp. | 2000 | — |
| −5 | K020623 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −4 | K022806 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −3 | K031594 | Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray | M.K. Meditech Co., Ltd. | 2003 | — |
| −2 | K042500 | Duopross Syringes | Duopross Meditech Corporation | 2005 | — |
| −1 | K060211 | Wuzhou Syringe, with/Without Needle | Wenzhou Wuzhou Group Co., Ltd. | 2006 | — |
| 0 (this device) | K222925 | Hypodermic Syringes & Needle | Lifelong Meditech Private Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K060211 | Wuzhou Syringe, with/Without NeedleSummary page 6…clip type) with K163162 Meditech Pvt. needle or without needle K060211 Ltd. for single use 3. Sterile hypodermic safety syringe(Needl… | 2006 |
| * | K102584 | Imc Hypodermic NeedleSummary page 6…Predicate Device Manufacturer Lifelong 4. Sterile Hypodermic needle for single Meditech Pvt. use K102584 Ltd. 6. Device Description The syringe consists of a plunger & gasket that’s fits tightly within a cylindrical tube called a… | 2011 |
| † | K163162 | Sterile Hypodermic Safety Syringes for Single Use | 2017 |
| † | K051694 | Clickzip Needle Retractable Safety Syringe | 2005 |
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 23 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 13 ancestors have a recall of any class.
- 2 other devices also cite its predicate K060211.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 hypodermic single use syringe with needle or without needle: The Sterile Hypodermic syringe with needle or without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body. Sterile hypodermic safety syringe (clip type) for single use with needle or without needle: The sterile hypodermic safety syringes for single use is intended to be used for medical purpose to inject fluids into or withdraw…
Read the full statement (190 words)
Sterile hypodermic single use syringe with needle or without needle:
The Sterile Hypodermic syringe with needle or without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
Sterile hypodermic safety syringe (clip type) for single use with needle or without needle:
The sterile hypodermic safety syringes for single use is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. After injection, the anti-needle stick feature is manually activated to aid in the prevention of accidental needle stick injuries.
Sterile hypodermic safety syringes (needle retractable type) for single use with needle:
The needle retractable safety syringe is to be used for intra-muscular or subcutaneous injection of medications into a patient and is intended to prevent needle stick injuries. Needle retractable safety syringe is not intended to be used for withdrawing blood. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.
Sterile hypodermic needle for single use:
The Sterile Hypodermic needle intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222925 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222925: Hypodermic Syringes & Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222925
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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