Cleared Traditional

K242438 - Clearo

K242438 is an FDA 510(k) clearance for Clearo, manufactured by Breas Medical AB. The device is a Class 2 Anesthesiology device with product code NHJ cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K242438 · Breas Medical AB · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
273d
Days
Class 2
Risk

K242438 is an FDA 510(k) clearance for the Clearo. Classified as Device, Positive Pressure Breathing, Intermittent (product code NHJ), Class II - Special Controls.

Submitted by Breas Medical AB (Molnlycke, SE). The FDA issued a Cleared decision on May 16, 2025 after a review of 273 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Breas Medical AB devices

FDA 510(k) Submission Details - K242438

510(k) Number K242438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2024
Decision Date May 16, 2025
Days to Decision 273 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
133d slower than avg
Panel avg: 140d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHJ Device Classification - Class 2, Special Controls

Product Code NHJ Device, Positive Pressure Breathing, Intermittent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - NHJ Device, Positive Pressure Breathing, Intermittent

All 11
Devices cleared under the same product code (NHJ) and FDA review panel - the closest regulatory comparables to K242438.
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