Cleared Traditional

K921815 - TOMEY PE-300 PORTABLE ERG

K921815 is an FDA 510(k) clearance for TOMEY PE-300 PORTABLE ERG, manufactured by Tomey Corporation USA. The device is a Class 2 Ophthalmic device with product code HLT cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K921815 · Tomey Corporation USA · Ophthalmic device
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Jul 1992
Decision
91d
Days
Class 2
Risk

K921815 is an FDA 510(k) clearance for the TOMEY PE-300 PORTABLE ERG. Classified as Preamplifier, Ac-powered, Ophthalmic (product code HLT), Class II - Special Controls.

Submitted by Tomey Corporation USA (Cambridge, US). The FDA issued a Cleared decision on July 15, 1992 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1640 - 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 Tomey Corporation USA devices

FDA 510(k) Submission Details - K921815

510(k) Number K921815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1992
Decision Date July 15, 1992
Days to Decision 91 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
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLT Device Classification - Class 2, Special Controls

Product Code HLT Preamplifier, Ac-powered, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1640
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 Ophthalmic devices follow this clearance model.