Cleared Traditional

K932720 - HM-0970

K932720 is an FDA 510(k) clearance for HM-0970, manufactured by Hill-Med, Inc.. The device is a Class 1 General & Plastic Surgery device with product code HRM cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K932720 · Hill-Med, Inc. · General & Plastic Surgery device
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Sep 1993
Decision
95d
Days
Class 1
Risk

K932720 is an FDA 510(k) clearance for the HM-0970. Classified as Microscope, Operating & Accessories, Ac-powered, Ophthalmic (product code HRM), Class I - General Controls.

Submitted by Hill-Med, Inc. (Miami, US). The FDA issued a Cleared decision on September 7, 1993 after a review of 95 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4700 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Hill-Med, Inc. devices

FDA 510(k) Submission Details - K932720

510(k) Number K932720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1993
Decision Date September 07, 1993
Days to Decision 95 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 115d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

HRM Device Classification - Class 1, General Controls

Product Code HRM Microscope, Operating & Accessories, Ac-powered, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4700
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 - HRM Microscope, Operating & Accessories, Ac-powered, Ophthalmic

All 9
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