510(k) Report

510(k) · Cleared

Recalled · Class III · 2014

Medtronic Everest Inflation Device

K942269510(k) TraditionalCleared Oct 18, 1994161-day reviewClass II21 CFR 870.1650Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronics Interventional Vascular · MAV Syringe, Balloon Inflation

Cleared on Oct 18, 1994 after a 161-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it. It has been recalled 5 times.

Decided
Oct 18, 1994
Review
161 days
Class
Class II
Product code
MAV
Recalls
5
Predicates
0

12 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2016: 5 descendants cleared2009: 1 descendant cleared2012: 1 descendant cleared2022: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared2017: 2 descendants cleared1990200020102020
  1. This deviceK942269 Medtronic Everest Inflation DeviceMedtronics Interventional Vascular · 1994
  2. Descendant · cites it directly · 9 of its ownK092174 Enabler-P Catheter System, Model 3000Endocross, Ltd. · 2009
  3. Descendant · 2 generations on · 8 of its ownK121763 Multicross Support CatheterRoxwood Medical, Inc. · 2012
  4. Descendant · 3 generations on · 3 of its ownK140910 Centercross CatheterRoxwood Medical, Inc. · 2014
  5. Descendant · 4 generations on · 2 of its ownK152456 CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016
  6. Descendant · 3 generations on · 2 of its ownK143608 NovaCross MicrocatheterNitiloop, Ltd. · 2015

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2009: 12012: 12014: 12015: 12016: 52017: 22022: 1
2009high 5 (2016) · low 0 (2010)2026

Most influential descendants

Showing 5 of 12 · See all
  • K092174Enabler-P Catheter System, Model 3000Endocross, Ltd. · 2009 · cites it directly9descendants
  • K121763Multicross Support CatheterRoxwood Medical, Inc. · 2012 · 2 generations on8descendants
  • K140910Centercross CatheterRoxwood Medical, Inc. · 2014 · 3 generations on3descendants
  • K152456CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016 · 4 generations on2descendants
  • K143608NovaCross MicrocatheterNitiloop, Ltd. · 2015 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942269Medtronic Everest Inflation DeviceMedtronics Interventional Vascular1994—
+1K092174Enabler-P Catheter System, Model 3000Endocross, Ltd.2009—
+2K121763Multicross Support CatheterRoxwood Medical, Inc.2012—
+3K140910Centercross CatheterRoxwood Medical, Inc.2014—
+4K152456CenterCross Ultra CatheterRoxwood Medical, Inc.2016—
+3K143608NovaCross MicrocatheterNitiloop, Ltd.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201210
201410
201510
201650
201720
202210
FIG. 1 — Lineage of K942269, 1994–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K260035 Digital Indeflator INFLANTEscore 12.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (12)

See all 12

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092174Enabler-P Catheter System, Model 3000Endocross, Ltd.20099
K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable…Medtronic, Inc.20161

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 6, 2014Class IIIZ-1121-2014Labeling mix-upsIncorrect master label.
Jul 16, 2010Not classifiedZ-2271-2010Packaging process controlProduct sterility may be compromised due to breach of package seal integrity.
Jul 16, 2010Not classifiedZ-2272-2010Packaging process controlProduct sterility may be compromised due to breach of package seal integrity.
Jul 16, 2010Not classifiedZ-2273-2010Packaging process controlProduct sterility may be compromised due to breach of package seal integrity.
Jan 31, 2003Not classifiedZ-0625-03OtherPTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K092174 (Endocross, Ltd., 2009) has gone furthest, with 9 descendants of its own.

How does its category compare?

All MAV devices

MAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAV

1in 2022

2008: 12011: 12012: 42013: 12014: 22015: 32016: 32022: 12026 (partial year): 1
2007high 4 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAV

69in 2016

2012: 85 days median2015: 116 days median2016: 69 days median
2007high 116 (2015) · low 69 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAV

4in 2024

2010: 32014: 22016: 12018: 12022: 52024: 4
2007high 5 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAV

66in 2025

2007: 372008: 502009: 992010: 882011: 942012: 2512013: 2452014: 922015: 1212016: 1242017: 2462018: 3002019: 1992020: 1012021: 1862022: 4372023: 2202024: 4202025: 66
2007high 437 (2022) · low 37 (2007)2025

MAUDE reports naming product code MAV, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—037
20081—050
20090—099
20100—388
20111—094
20124850251
20131—0245
20142—292
201531160121
20163691124
20170—0246
20180—1300
20190—0199
20200—0101
20210—0186
20221—5437
20230—0220
20240—4420
20250—066
20261—0—

More from Medtronics Interventional Vascular

66 FDA decisions under this applicant name. See the company

  • K990707Medtronic 5F & 9F Zuma Guiding CathetersMedtronics Interventional Vascular · 19995 recalls
  • K980973Medtronic Angiographic CatheterMedtronics Interventional Vascular · 1998
  • P870036/S044The Medtronic Achiever Coronary Ballon Dilation CatheterMedtronics Interventional Vascular · 1998
  • K982883Medtronic 7F and 8F Zuma Guiding CatheterMedtronics Interventional Vascular · 199810 recalls
  • K981198Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 199825 recalls

Recent decisions in MAV

The MAV category page

  • K260035Digital Indeflator INFLANTEUAB Telemedicina · 2026
  • K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock…Medtronic Vascular · 2022
  • K162272Fluent inflation deviceVascular Solutions, Inc. · 2016
  • K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device…Medtronic, Inc. · 2016
  • K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc. · 2016

https://510kreport.com/device/K942269 · printed Nov 4, 2026

Cite this page

510(k) Report. “K942269: Medtronic Everest Inflation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K942269

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026