510(k) · Cleared
Recalled · 2010Medtronic Everst 30 Inflation Device/Survival Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronics Interventional Vascular · MAV Syringe, Balloon Inflation
Cleared on May 30, 1996 after an 80-day review. The FDA summary names no predicate by number. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- May 30, 1996
- Review
- 80 days
- Class
- Class II
- Product code
- MAV
- Recalls
- 3
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK960983 Medtronic Everst 30 Inflation Device/Survival KitMedtronics Interventional Vascular · 1996
- Descendant · cites it directly · 1 of its ownK153038 Everest 20 Disposable Inflation Device, Everest 20 Survival Kit…Medtronic, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK220773 Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30…Medtronic Vascular · 2022
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 |
|---|---|---|---|---|---|
| 0 (this device) | K960983 | Medtronic Everst 30 Inflation Device/Survival Kit | Medtronics Interventional Vascular | 1996 | — |
| +1 | K153038 | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30… | Medtronic, Inc. | 2016 | — |
| +2 | K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation… | Medtronic Vascular | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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.
Planning a device in MAV? 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 MAV device
- #1 K260035 Digital Indeflator INFLANTEscore 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K153038 | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable… | 2016 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2010 | Not classified | Z-2271-2010 | Packaging process control | Product sterility may be compromised due to breach of package seal integrity. |
| Jul 16, 2010 | Not classified | Z-2272-2010 | Packaging process control | Product sterility may be compromised due to breach of package seal integrity. |
| Jul 16, 2010 | Not classified | Z-2273-2010 | Packaging process control | Product sterility may be compromised due to breach of package seal integrity. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K153038 (Medtronic, Inc., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MAV devicesMAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAV
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MAV
69in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAV
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAV
66in 2025
MAUDE reports naming product code MAV, 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 | 0 | — | 0 | 37 |
| 2008 | 1 | — | 0 | 50 |
| 2009 | 0 | — | 0 | 99 |
| 2010 | 0 | — | 3 | 88 |
| 2011 | 1 | — | 0 | 94 |
| 2012 | 4 | 85 | 0 | 251 |
| 2013 | 1 | — | 0 | 245 |
| 2014 | 2 | — | 2 | 92 |
| 2015 | 3 | 116 | 0 | 121 |
| 2016 | 3 | 69 | 1 | 124 |
| 2017 | 0 | — | 0 | 246 |
| 2018 | 0 | — | 1 | 300 |
| 2019 | 0 | — | 0 | 199 |
| 2020 | 0 | — | 0 | 101 |
| 2021 | 0 | — | 0 | 186 |
| 2022 | 1 | — | 5 | 437 |
| 2023 | 0 | — | 0 | 220 |
| 2024 | 0 | — | 4 | 420 |
| 2025 | 0 | — | 0 | 66 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Indications for the Medtronic® Everest™ 30 Inflation Device / Survival Kit are identical to those for commercially available inflation devices. The devices are used for the inflation / deflation of balloon dilatation catheters. These devices are intended for single use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960983: Medtronic Everst 30 Inflation Device/Survival Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960983
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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