Cleared Traditional

K914416 - BREATH-EASY, MODIFICATION (FDA 510(k) Clearance)

Class I Ophthalmic device.

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

Submission Details

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.

Device Classification

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.