510(k) · Decided
DecidedEverest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · MAV Syringe, Balloon Inflation
Cleared on Apr 13, 2016 as substantially equivalent to K942269 (Medtronics Interventional Vascular, 1994) and 1 other predicate after a 177-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Apr 13, 2016
- Review
- 177 days
- Class
- Class II
- Product code
- MAV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942269 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK942269 Medtronic Everest Inflation DeviceMedtronics Interventional Vascular · 1994 · Recalled
- This deviceK153038 Everest 20 Disposable Inflation Device, Everest 20 Survival Kit…Medtronic, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK220773 Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30…Medtronic Vascular · 2022
Most influential descendants
Showing 1 of 1 · See all- K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and…Medtronic Vascular · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942269 | Medtronic Everest Inflation Device | Medtronics Interventional Vascular | 1994 | 5 |
| 0 (this device) | K153038 | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30… | Medtronic, Inc. | 2016 | — |
| +1 | K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation… | Medtronic Vascular | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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.
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? (2)
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 |
|---|---|---|---|
| * | K942269 | Medtronic Everest Inflation DeviceSummary page 4…vices legally marketed currently were used as predicate devices in this 510(k) premarket notification: 1. K942269 (Medtronic Everest™ 20 Inflation Device) 2. K960983 (Medtronic Everest™ 30 Inflation Device,… | 1994 |
| * | K960983 | Medtronic Everst 30 Inflation Device/Survival KitSummary page 4…devices in this 510(k) premarket notification: 1. K942269 (Medtronic Everest™ 20 Inflation Device) 2. K960983 (Medtronic Everest™ 30 Inflation Device, Survival Kit) Device Medtronic’s Everest™ Dispos… | 1996 |
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 |
|---|---|---|---|
| K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and… | 2022 | 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?
How does its category compare?
All MAV devicesMAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 Everest 20cc Inflation Device/ Survival Kit is to be used to facilitate the use of catheters and guide wires during interventional procedures. The Everest 20cc Inflation Device is designed to be used to inflate/ deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adaptor with Hemostasis Valve is designed to be used on a guiding catheter or dilatation catheter to control backbleeding and to provide a port for…
Read the full statement (129 words)
The Everest 20cc Inflation Device/ Survival Kit is to be used to facilitate the use of catheters and guide wires during interventional procedures. The Everest 20cc Inflation Device is designed to be used to inflate/ deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adaptor with Hemostasis Valve is designed to be used on a guiding catheter or dilatation catheter to control backbleeding and to provide a port for introduction of fluids into the interventional system. The Guide Wire Insertion Tool is designed to facilitate placement of a guide wire tip through the Y/Tri-Adapter and into the wire lumen of an interventional catheter. The Guide Wire Steering Handle is designed to hold a small diameter guide wire and provide a handle for manipulating the wire.
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/K153038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153038: Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 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/K153038
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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