Cleared Traditional

PART #860070 ULTRAPAK & #860075 ULTRAPAK (K871474) - FDA 510(k) Clearance

Class I Ophthalmic device.

K871474 · Medical Technical Products · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1987
Decision
118d
Days
Class 1
Risk

K871474 is an FDA 510(k) clearance for the PART #860070 ULTRAPAK & #860075 ULTRAPAK. Classified as Clip, Iris Retractor (product code HOC), Class I - General Controls.

Submitted by Medical Technical Products (Irvine, US). The FDA issued a Cleared decision on August 10, 1987 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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 Medical Technical Products devices

Submission Details

510(k) Number K871474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1987
Decision Date August 10, 1987
Days to Decision 118 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 110d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOC Clip, Iris Retractor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
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.