Cleared Traditional

BREATHE EASY, MODELS AD AND CD (K981841) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981841 · Respiraid , Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 1998
Decision
140d
Days
Class 2
Risk

K981841 is an FDA 510(k) clearance for the BREATHE EASY, MODELS AD AND CD. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Respiraid , Ltd. (Ra'Ananna 43373, IL). The FDA issued a Cleared decision on October 13, 1998 after a review of 140 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5045 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Respiraid , Ltd. devices

Submission Details

510(k) Number K981841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1998
Decision Date October 13, 1998
Days to Decision 140 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 129d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRF Cleaner, Air, Medical Recirculating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5045
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 General Hospital devices follow this clearance model.