510(k) Report

510(k) · Cleared

Cleared

Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter Model

K100063510(k) SpecialCleared Feb 2, 201022-day reviewClass II21 CFR 870.4450

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

Ev3, Inc. · MJN Catheter, Intravascular Occluding, Temporary

Cleared on Feb 2, 2010 as substantially equivalent to K092495 (Ev3 Neurovascular, 2009) and 4 other predicates after a 22-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.

Decided
Feb 2, 2010
Review
22 days
Class
Class II
Product code
MJN
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K011526 (2001). 7 ancestors in all, the oldest K001237 (2000). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor2010: 1 descendant cleared2013: 1 descendant clearedK011526 · Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123 · Micro Therapeutics, Inc. · 2001K090728 · Hyperglide Occlusion Balloon System · Ev3, Inc. · 2009K092495 · Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315 · Ev3 Neurovascular · 2009200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K092495 · Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315 · Ev3 Neurovascular · 2009K090728 · Hyperglide Occlusion Balloon System · Ev3, Inc. · 2009K011526 · Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123 · Micro Therapeutics, Inc. · 20010
  1. Root · 3 generations backK011526 Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121…Micro Therapeutics, Inc. · 2001
  2. 2 generations backK090728 Hyperglide Occlusion Balloon SystemEv3, Inc. · 2009
  3. 1 generation backK092495 Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315Ev3 Neurovascular · 2009
  4. This deviceK100063 Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon…Ev3, Inc. · 2010
  5. Descendant · cites it directly · 1 of its ownK101570 Hyperglide and Hyperform Occlusion Balloon SystemsMicro Therapeutics Dba Ev3 Neurovascular · 2010
  6. Descendant · 2 generations on · 0 of its ownK122576 Transform Occlusion Balloon Catheter (Compliant and Super CompliantStryker Neurovascular · 2013 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K101570Hyperglide and Hyperform Occlusion Balloon SystemsMicro Therapeutics Dba Ev3 Neurovascular · 2010 · cites it directly1descendant
  • K122576Transform Occlusion Balloon Catheter (Compliant and Super CompliantStryker Neurovascular · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K011526Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129…Micro Therapeutics, Inc.2001—
−2K090728Hyperglide Occlusion Balloon SystemEv3, Inc.2009—
−1K092495Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315Ev3 Neurovascular2009—
0 (this device)K100063Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter…Ev3, Inc.2010—
+1K101570Hyperglide and Hyperform Occlusion Balloon SystemsMicro Therapeutics Dba Ev3 Neurovascular2010—
+2K122576Transform Occlusion Balloon Catheter (Compliant and Super CompliantStryker Neurovascular20138

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200110
200210
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201310
FIG. 1 — Lineage of K100063, 2001–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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 MJN? 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 MJN device

  1. #1 K243795 pREBOA-PRO Catheterscore 12.1 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K092495Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315
Summary page 1
…ame: Occlusion Balloon Catheter Predicate Devices - 510(k) References HyperGlide~m Occlusion Balloon Catheter K092495 HyperGlide Tm and HyperForm~m Occlusion Balloon Catheters K091458 HyperGlide~m Occlusion Balloon Catheter…
Ev3 Neurovascular2009—
*K091458Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112…
Summary page 1
…k) References HyperGlide~m Occlusion Balloon Catheter K092495 HyperGlide Tm and HyperForm~m Occlusion Balloon Catheters K091458 HyperGlide~m Occlusion Balloon Catheter K090728 HyperGlide~m Occlusion Balloon Catheter…
Ev3 Neurovascular2009—
*K090728Hyperglide Occlusion Balloon System
Summary page 1
…K092495 HyperGlide Tm and HyperForm~m Occlusion Balloon Catheters K091458 HyperGlide~m Occlusion Balloon Catheter K090728 HyperGlide~m Occlusion Balloon Catheter K021 066 HyperFormTm Occlusion Balloon Catheter…
Ev3, Inc.2009—
*K021066Modification to Hyperglide Occlusion Balloon System
Summary page 1
…K091458 HyperGlide~m Occlusion Balloon Catheter K090728 HyperGlide~m Occlusion Balloon Catheter K021 066 HyperFormTm Occlusion Balloon Catheter K01 1656 Description of the Device Subject to…
Micro Therapeutics, Inc.2002—
*K011656Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771
Summary page 1
…K090728 HyperGlide~m Occlusion Balloon Catheter K021 066 HyperFormTm Occlusion Balloon Catheter K01 1656 Description of the Device Subject to Premarket Notification The Occlusion Balloon Catheter is a single lumen bal…
Micro Therapeutics, Inc.2001—

Also cleared against K092495: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K101570Hyperglide and Hyperform Occlusion Balloon SystemsMicro Therapeutics Dba Ev3 Neurovascular20101

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 9 years and passes through 3 companies; a new generation was cleared every 5 months on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K101570 (Micro Therapeutics Dba Ev3 Neurovascular, 2010) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K092495.

How does its category compare?

All MJN devices

MJN Catheter, Intravascular Occluding, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MJN

2in 2025

2007: 22008: 32009: 52010: 52011: 42012: 22013: 42014: 22015: 42016: 32017: 32018: 32019: 32020: 42021: 42022: 22023: 12025: 2
2007high 5 (2009) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MJN

116in 2021

2008: 153 days median2009: 39 days median2010: 30 days median2011: 69 days median2013: 87 days median2015: 245 days median2016: 110 days median2017: 54 days median2018: 63 days median2019: 117 days median2020: 64 days median2021: 116 days median
2007high 245 (2015) · low 30 (2010)2026

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

Recalls per year · MJN

1in 2020

2008: 22010: 12011: 12013: 82015: 12016: 22018: 12020: 1
2007high 8 (2013) · low 0 (2007)2026

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

Adverse event reports per year · MJN

194in 2025

2007: 252008: 262009: 252010: 352011: 922012: 532013: 762014: 1002015: 902016: 712017: 1572018: 1072019: 1392020: 1572021: 1582022: 1482023: 1812024: 2242025: 194
2007high 224 (2024) · low 25 (2007)2025

MAUDE reports naming product code MJN, 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
20072—025
20083153226
2009539025
2010530135
2011469192
20122—053
2013487876
20142—0100
20154245190
20163110271
20173540157
20183631107
201931170139
20204641157
202141160158
20222—0148
20231—0181
20240—0224
20252—0194
20260—0—

What is it indicated for?

The HyperForM TM Occlusion Balloon Catheters are indicated for the use in blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired. These catheters offer (1) a vessel selective technique of temporary vascular occlusion, Which is useful in selectively stopping or controlling blood flow, and (2) for balloon-assisted embolization of intracranial aneurysms.

Indications for use as stated in the FDA summary.

Also cleared against K092495

1 other device cites the same predicate.

  • K101570Hyperglide and Hyperform Occlusion Balloon SystemsMicro Therapeutics Dba Ev3 Neurovascular · 2010

More from Ev3, Inc.

35 FDA decisions under this applicant name. See the company

  • K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 20141 recall
  • K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013
  • K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013
  • K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013
  • K111723Turbohawk Peripheral Plaque Excision SystemEv3, Inc. · 20111 recall

Recent decisions in MJN

The MJN category page

  • K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc. · 2025
  • K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy Devices · 2025
  • K221294preCARDIA Occlusion SystemAbiomed, Inc. · 2023
  • K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc. · 2022
  • K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLC · 2022

https://510kreport.com/device/K100063 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100063: Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100063

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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