Cleared Traditional

K260035 - Digital Indeflator INFLANTE

K260035 is an FDA 510(k) clearance for Digital Indeflator INFLANTE, manufactured by UAB Telemedicina. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K260035 · UAB Telemedicina · Cardiovascular device
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Sep 2026
Decision
241d
Days
Class 2
Risk

K260035 is an FDA 510(k) clearance for the Digital Indeflator INFLANTE. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by UAB Telemedicina (Kaunas, LT). The FDA issued a Cleared decision on September 4, 2026 after a review of 241 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all UAB Telemedicina devices

FDA 510(k) Submission Details - K260035

510(k) Number K260035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2026
Decision Date September 04, 2026
Days to Decision 241 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 125d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAV Device Classification - Class 2, Special Controls

Product Code MAV Syringe, Balloon Inflation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MAV Syringe, Balloon Inflation

All 49
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K260035.
Everest 20 Inflation Device and 3-way Stopcock (AC2200)
K220773 · Medtronic Vascular · Apr 2022
Fluent inflation device
K162272 · Vascular Solutions, Inc. · Oct 2016
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
K153038 · Medtronic, Inc. · Apr 2016
basixTOUCH40 Inflation Syringe
K153672 · Merit Medical Systems, Inc. · Jan 2016
Fluent Inflation Device
K152387 · Vascular Solutions, Inc. · Dec 2015
MASTRO PLUS BALLOON IN-DEFLATION DEVICE
K140943 · Beijing Demax Medical Technology Co.,Ltd · Mar 2015