510(k) · Cleared
Recalled · Class II · 2020Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML)
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 Aug 20, 2010 as substantially equivalent to K081436 (Inviro Medical Devices, Inc., 2008) after a 98-day review. Its family tree reaches back 3 generations to 2005. 1 of the 5 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 20, 2010
- Review
- 98 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042102 (2005). 1 later device descends from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK042102 Yixin Safety SyringeJiangxi Sanxin (Eversincere) Medical Devices Group · 2005
- 2 generations backK050999 YI Xin Sterile Syringe for Single UseJiangxi Sanxin (Eversincere) Medical Devices Group · 2005 · Recalled (Class I)
- 1 generation backK081436 Invirostripe 3ML, 5ML, 10ML Luer Lock SyringesInviro Medical Devices, Inc. · 2008
- This deviceK101359 Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML)Inviro Medical Devices, Inc. · 2010
- Descendant · cites it directly · 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 Use2 generations back · 2005
Most influential descendants
Showing 1 of 1 · See all- K222744Sol-M Luer Lock SyringeSol-Millennium Medical, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042102 | Yixin Safety Syringe | Jiangxi Sanxin (Eversincere) Medical Devices Group | 2005 | — |
| −2 | K050999 | YI Xin Sterile Syringe for Single Use | Jiangxi Sanxin (Eversincere) Medical Devices Group | 2005 | Class I |
| −1 | K081436 | Invirostripe 3ML, 5ML, 10ML Luer Lock Syringes | Inviro Medical Devices, Inc. | 2008 | — |
| 0 (this device) | K101359 | Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML) | Inviro Medical Devices, Inc. | 2010 | — |
| +1 | K222744 | Sol-M Luer Lock Syringe | Sol-Millennium Medical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K081436 | Invirostripe 3ML, 5ML, 10ML Luer Lock SyringesSummary page 2…er. C. Predicate Device: InviroStripe 3, 5 and 10 ml Standard Luer Lock syringes Predicate 510(k) #: K08 1436 Predicate product code: FMF D. Device Description The InviroStripe 1, 3, 5, 10, 20, 30 and 60 ml Standard Luer… | 2008 |
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 |
|---|---|---|---|
| K222744 | Sol-M Luer Lock Syringe | 2022 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2020 | Class II | Z-1453-2020 | Under Investigation by firm | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in… |
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 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K222744 (Sol-Millennium Medical, Inc., 2022) has gone furthest, with 0 descendants 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. 2010, 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 Standard Luer Lock Syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101359: Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101359
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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