Cleared Traditional

MSP OPHTHALMIC (EYE SPUD) (K931449) - FDA 510(k) Clearance

Class I Ophthalmic device.

K931449 · Medical Sterile Products, Inc. · Ophthalmic device
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Aug 1993
Decision
161d
Days
Class 1
Risk

K931449 is an FDA 510(k) clearance for the MSP OPHTHALMIC (EYE SPUD). Classified as Spud, Ophthalmic (product code HNA), Class I - General Controls.

Submitted by Medical Sterile Products, Inc. (Rincon, US). The FDA issued a Cleared decision on August 31, 1993 after a review of 161 days - an extended review cycle.

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 Sterile Products, Inc. devices

Submission Details

510(k) Number K931449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1993
Decision Date August 31, 1993
Days to Decision 161 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
51d slower than avg
Panel avg: 110d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNA Spud, Ophthalmic
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.