Cleared Traditional

K261360 - EasyCare Tx 2

K261360 is an FDA 510(k) clearance for EasyCare Tx 2, manufactured by ResMed Corp. The device is a Class 2 Anesthesiology device with product code MOD cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K261360 · ResMed Corp · Anesthesiology device
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Aug 2026
Decision
125d
Days
Class 2
Risk

K261360 is an FDA 510(k) clearance for the EasyCare Tx 2. Classified as Accessory To Continuous Ventilator (respirator) (product code MOD), Class II - Special Controls.

Submitted by ResMed Corp (San Diego, US). The FDA issued a Cleared decision on August 27, 2026 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all ResMed Corp devices

FDA 510(k) Submission Details - K261360

510(k) Number K261360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2026
Decision Date August 27, 2026
Days to Decision 125 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 140d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOD Device Classification - Class 2, Special Controls

Product Code MOD Accessory To Continuous Ventilator (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 Anesthesiology devices follow this clearance model.

Regulatory Consultant

Resmed Pty , Ltd.
Lawrence Kwan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MOD Accessory To Continuous Ventilator (respirator)

All 7
Devices cleared under the same product code (MOD) and FDA review panel - the closest regulatory comparables to K261360.
Valence InVent Xtend™ (CVG-4101-VXA)
K253807 · Convergence Medical Sciences , Ltd. · Aug 2026
CorVision® (91-205-Z0014)
K260051 · Corvent Medical, Inc. · May 2026
EveryWare
K242485 · Breas Medical AB · May 2025
Care Cycle Connect Application
K161411 · Respironics, Inc. · Feb 2017
IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
K022062 · Impact Instrumentation, Inc. · May 2003
VENTNET
K963633 · Puritan Bennett Corp. · Dec 1996