510(k) · Cleared
ClearedInvirolink and Inviro Tip Blunt Cannulas, Model 130001, 130501, 140001, 140002, 140003
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inviro Medical Devices, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Feb 12, 2008 as substantially equivalent to K013087 (Alaris Medical Systems, Inc., 2001) after a 279-day review. Its family tree reaches back 2 generations to 1979. 2 later devices descend from it.
- Decided
- Feb 12, 2008
- Review
- 279 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K790472 (1979). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK790472 Burron Vented NeedleNational Patent Development Corp. · 1979
- 1 generation backK013087 Single Dose Dispensing Pin, Model 2201Alaris Medical Systems, Inc. · 2001
- This deviceK071307 Invirolink and Inviro Tip Blunt Cannulas, Model 130001, 130501…Inviro Medical Devices, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK083851 Inviroblunt Cannula with and Without EZ Wings, Models 120522 and…Inviro Medical Devices, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK202732 SOL-CARE IV Bag Safety ConnectorSol-Millennium Medical Group · 2021
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 | K790472 | Burron Vented Needle | National Patent Development Corp. | 1979 | — |
| −1 | K013087 | Single Dose Dispensing Pin, Model 2201 | Alaris Medical Systems, Inc. | 2001 | — |
| 0 (this device) | K071307 | Invirolink and Inviro Tip Blunt Cannulas, Model 130001, 130501, 140001… | Inviro Medical Devices, Inc. | 2008 | — |
| +1 | K083851 | Inviroblunt Cannula with and Without EZ Wings, Models 120522 and 120022 | Inviro Medical Devices, Inc. | 2009 | — |
| +2 | K202732 | SOL-CARE IV Bag Safety Connector | Sol-Millennium Medical Group | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2021 | 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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 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 |
|---|---|---|---|
| * | K013087 | Single Dose Dispensing Pin, Model 2201Summary page 2…ate Device: Alaris Medical Systems, Inc. Single Dose Dispensing Pin Predicate 5 10(k) #: K013087 Predicate product code: LHI D. Device Description The InviroLink/InviroTip Plastic Cannula were d… | 2001 |
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 |
|---|---|---|---|
| K083851 | Inviroblunt Cannula with and Without EZ Wings, Models 120522 and 120022 | 2009 | 1 |
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 29 years and passes through 3 companies; a new generation was cleared every 22.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K083851 (Inviro Medical Devices, Inc., 2009) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K013087.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The InviroLink and InviroLink w/EZ Wings Plastic Cannulas are used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septurns covering injection sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071307 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071307: Invirolink and Inviro Tip Blunt Cannulas, Model 130001, 130501, 140001, 140002, 140003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071307
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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