510(k) · Cleared
ClearedSafeway, Lifelong Premium, Lifelong Matrix
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 16, 2021 as substantially equivalent to K060211 (Wenzhou Wuzhou Group Co., Ltd., 2006) after a 183-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jul 16, 2021
- Review
- 183 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000572 (2000). 10 ancestors in all, the oldest K980987 (1998). 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 deviceK210103 Safeway, Lifelong Premium, Lifelong MatrixLifelong Meditech Private Limited · 2021
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) | K210103 | Safeway, Lifelong Premium, Lifelong Matrix | Lifelong Meditech Private Limited | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K060211 | Wuzhou Syringe, with/Without NeedleSummary page 4…n Needle- 21 CFR 880.5570 Device Code: • FMF- Piston Syringe • FMI - Hypodermic Single Lumen Needle Device Class: Class II 3.5 Predicate Device: K060211 - Wuzhou Syringe with/without needle Page… | 2006 |
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 21 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 10 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. 2021, 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?
Lifelong Matrix/Lifelong Premium/Safeway syringe with or without needle is 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/K210103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210103: Safeway, Lifelong Premium, Lifelong Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210103
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