Cleared Traditional

K974414 - MULTI

K974414 is an FDA 510(k) clearance for MULTI, manufactured by Morning Calm Corp.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K974414 · Morning Calm Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
14d
Days
Class 1
Risk

K974414 is an FDA 510(k) clearance for the MULTI. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Morning Calm Corp. (Daegu, KR). The FDA issued a Cleared decision on December 8, 1997 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5850 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Morning Calm Corp. devices

FDA 510(k) Submission Details - K974414

510(k) Number K974414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1997
Decision Date December 08, 1997
Days to Decision 14 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 110d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

HQY Device Classification - Class 1, General Controls

Product Code HQY Sunglasses (non-prescription Including Photosensitive)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5850
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.

Regulatory Peers - HQY Sunglasses (non-prescription Including Photosensitive)

All 62
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K974414.
SUNGLASSES
K974511 · Sun World Intl., Inc. · Jan 1998
SUNGLASSES
K974441 · Hip Shing Fat Co., Ltd. · Jan 1998
SUNGLASSES
K973528 · Jeou Jeou Long Industrial Co., Ltd. · Dec 1997
NON-PRESCRIPTION SUNGLASSES
K974179 · Taipan Optical Company , Ltd. · Dec 1997
VENNETO
K974045 · Amsure Sports, Inc. · Nov 1997
SUNGLASSES
K973934 · Elegance Optical Manufactory, Ltd. · Nov 1997