Cleared Traditional

K253807 - Valence InVent Xtend™ (CVG-4101-VXA)

K253807 is an FDA 510(k) clearance for Valence InVent Xtend (CVG-4101-VXA), manufactured by Convergence Medical Sciences , Ltd.. The device is a Class 2 Anesthesiology device with product code MOD cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K253807 · Convergence Medical Sciences , Ltd. · Anesthesiology device
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Aug 2026
Decision
265d
Days
Class 2
Risk

K253807 is an FDA 510(k) clearance for the Valence InVent Xtend™ (CVG-4101-VXA). Classified as Accessory To Continuous Ventilator (respirator) (product code MOD), Class II - Special Controls.

Submitted by Convergence Medical Sciences , Ltd. (Calgary, CA). The FDA issued a Cleared decision on August 20, 2026 after a review of 265 days - an extended review cycle.

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 Convergence Medical Sciences , Ltd. devices

FDA 510(k) Submission Details - K253807

510(k) Number K253807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2025
Decision Date August 20, 2026
Days to Decision 265 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
125d slower than avg
Panel avg: 140d · This submission: 265d
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 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 K253807.
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IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
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VENTNET
K963633 · Puritan Bennett Corp. · Dec 1996