Cleared Traditional

K914416 - BREATH-EASY, MODIFICATION

K914416 is an FDA 510(k) clearance for BREATH-EASY, manufactured by Icor AB. The device is a Class 1 Ophthalmic device with product code HME cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K914416 · Icor AB · Ophthalmic device
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Jun 1992
Decision
272d
Days
Class 1
Risk

K914416 is an FDA 510(k) clearance for the BREATH-EASY, MODIFICATION. Classified as Chair, Ophthalmic, Ac-powered (product code HME), Class I - General Controls.

Submitted by Icor AB (Bromma, SE). The FDA issued a Cleared decision on June 23, 1992 after a review of 272 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1140 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Icor AB devices

FDA 510(k) Submission Details - K914416

510(k) Number K914416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1991
Decision Date June 23, 1992
Days to Decision 272 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 110d · This submission: 272d
Pathway characteristics
Predicate-based equivalence.

HME Device Classification - Class 1, General Controls

Product Code HME Chair, Ophthalmic, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1140
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.