510(k) · Cleared
ClearedInviroblunt Cannula with and Without EZ Wings, Models 120522 and 120022
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inviro Medical Devices, Inc. · LHI Set, I.V. Fluid Transfer
Cleared on May 15, 2009 as substantially equivalent to K071307 (Inviro Medical Devices, Inc., 2008) after a 142-day review. Its family tree reaches back 3 generations to 1979. 1 later device descends from it.
- Decided
- May 15, 2009
- Review
- 142 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K790472 (1979). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK790472 Burron Vented NeedleNational Patent Development Corp. · 1979
- 2 generations backK013087 Single Dose Dispensing Pin, Model 2201Alaris Medical Systems, Inc. · 2001
- 1 generation backK071307 Invirolink and Inviro Tip Blunt Cannulas, Model 130001, 130501…Inviro Medical Devices, Inc. · 2008
- This deviceK083851 Inviroblunt Cannula with and Without EZ Wings, Models 120522 and…Inviro Medical Devices, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK202732 SOL-CARE IV Bag Safety ConnectorSol-Millennium Medical Group · 2021
Most influential descendants
Showing 1 of 1 · See all- K202732SOL-CARE IV Bag Safety ConnectorSol-Millennium Medical Group · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K790472 | Burron Vented Needle | National Patent Development Corp. | 1979 | — |
| −2 | K013087 | Single Dose Dispensing Pin, Model 2201 | Alaris Medical Systems, Inc. | 2001 | — |
| −1 | K071307 | Invirolink and Inviro Tip Blunt Cannulas, Model 130001, 130501, 140001… | Inviro Medical Devices, Inc. | 2008 | — |
| 0 (this device) | K083851 | Inviroblunt Cannula with and Without EZ Wings, Models 120522 and 120022 | Inviro Medical Devices, Inc. | 2009 | — |
| +1 | 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 |
|---|---|---|
| 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 LHI? 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 LHI device
- #1 K252987 ADRx™ Admixture Devicescore 12.4 · 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 |
|---|---|---|---|
| * | K071307 | Invirolink and Inviro Tip Blunt Cannulas, Model 130001, 130501, 140001, 140002, 140003Summary page 2…InviroLink and InviroLink w/EZ Wings Cannula Predicate 5 10(k) #: K071307 Predicate product code: LH[ D. Device Description The InviroBlunt/InviroBlunt Cannula were designed… | 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 |
|---|---|---|---|
| K202732 | SOL-CARE IV Bag Safety Connector | 2021 | 0 |
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 30 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K202732 (Sol-Millennium Medical Group, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LHI devicesLHI Set, I.V. Fluid Transfer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LHI
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHI
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHI
1in 2024
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · LHI
1,334in 2025
MAUDE reports naming product code LHI, 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 | 3 | 89 | 1 | 18 |
| 2008 | 4 | 154 | 3 | 27 |
| 2009 | 8 | 95 | 1 | 37 |
| 2010 | 5 | 139 | 3 | 49 |
| 2011 | 3 | 99 | 12 | 155 |
| 2012 | 5 | 127 | 0 | 529 |
| 2013 | 4 | 102 | 3 | 154 |
| 2014 | 6 | 63 | 0 | 155 |
| 2015 | 3 | 99 | 0 | 128 |
| 2016 | 3 | 159 | 1 (1) | 219 |
| 2017 | 5 | 56 | 1 | 536 |
| 2018 | 1 | — | 3 (3) | 1,499 |
| 2019 | 4 | 247 | 1 | 1,634 |
| 2020 | 3 | 189 | 0 | 1,171 |
| 2021 | 3 | 396 | 0 | 933 |
| 2022 | 6 | 278 | 2 | 1,834 |
| 2023 | 5 | 90 | 2 (2) | 1,047 |
| 2024 | 9 | 166 | 1 | 1,270 |
| 2025 | 6 | 196 | 0 | 1,334 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The InviroBlunt and InviroBlunt w/EZ Wings 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 septums covering injection sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083851: Inviroblunt Cannula with and Without EZ Wings, Models 120522 and 120022.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083851
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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