Cleared Traditional

K842410 - AMER. EDWARDS LAB FLEXISCOPE

K842410 is an FDA 510(k) clearance for AMER. EDWARDS LAB FLEXISCOPE, manufactured by American Edwards Laboratories. The device is a Class 1 Ophthalmic device with product code HRK cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K842410 · American Edwards Laboratories · Ophthalmic device
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Nov 1984
Decision
139d
Days
Class 1
Risk

K842410 is an FDA 510(k) clearance for the AMER. EDWARDS LAB FLEXISCOPE. Classified as Table, Instrument, Manual, Ophthalmic (product code HRK), Class I - General Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on November 5, 1984 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4855 - 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 American Edwards Laboratories devices

FDA 510(k) Submission Details - K842410

510(k) Number K842410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1984
Decision Date November 05, 1984
Days to Decision 139 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 110d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

HRK Device Classification - Class 1, General Controls

Product Code HRK Table, Instrument, Manual, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4855
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.