510(k) · Cleared
ClearedInvirostripe 3ML, 5ML, 10ML Luer Lock Syringes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inviro Medical Devices, Inc. · FMF Syringe, Piston
Cleared on Oct 22, 2008 as substantially equivalent to K050999 (Jiangxi Sanxin (Eversincere) Medical Devices Group, 2005) after a 154-day review. Its family tree reaches back 2 generations to 2005. 1 of the 5 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Oct 22, 2008
- Review
- 154 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042102 (2005). 2 later devices descend from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK042102 Yixin Safety SyringeJiangxi Sanxin (Eversincere) Medical Devices Group · 2005
- 1 generation backK050999 YI Xin Sterile Syringe for Single UseJiangxi Sanxin (Eversincere) Medical Devices Group · 2005 · Recalled (Class I)
- This deviceK081436 Invirostripe 3ML, 5ML, 10ML Luer Lock SyringesInviro Medical Devices, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK101359 Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML)Inviro Medical Devices, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 0 of its ownK222744 Sol-M Luer Lock SyringeSol-Millennium Medical, Inc. · 2022
Class I recalls in this family
- K050999 YI Xin Sterile Syringe for Single Usedirect predicate · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042102 | Yixin Safety Syringe | Jiangxi Sanxin (Eversincere) Medical Devices Group | 2005 | — |
| −1 | K050999 | YI Xin Sterile Syringe for Single Use | Jiangxi Sanxin (Eversincere) Medical Devices Group | 2005 | Class I |
| 0 (this device) | K081436 | Invirostripe 3ML, 5ML, 10ML Luer Lock Syringes | Inviro Medical Devices, Inc. | 2008 | — |
| +1 | K101359 | Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML) | Inviro Medical Devices, Inc. | 2010 | 1 |
| +2 | K222744 | Sol-M Luer Lock Syringe | Sol-Millennium Medical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2022 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K050999 | YI Xin Sterile Syringe for Single UseSummary page 1…Reason for 510(k): New Device C. Predicate Device: Yi Xin Sterile Syringe for Single Use Predicate 510(k) #: K050999 Predicate product code: FMF D. Device Description The InviroStripe Standard 3, 5 and 10 m… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101359 | Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML) | 2010 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K050999YI Xin Sterile Syringe for Single UseJiangxi Sanxin (Eversincere) Medical Devices Group · 2005 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K101359 (Inviro Medical Devices, Inc., 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 InviroStripe 3, 5 and 10 ml Standard Luer Lock Syringes are used to inject medicines into, or withdraw fluids from the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081436: Invirostripe 3ML, 5ML, 10ML Luer Lock Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081436
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