Cleared Traditional

K931449 - MSP OPHTHALMIC (EYE SPUD)

K931449 is an FDA 510(k) clearance for MSP OPHTHALMIC (EYE SPUD), manufactured by Medical Sterile Products, Inc.. The device is a Class 1 Ophthalmic device with product code HNA cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K931449 · Medical Sterile Products, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K931449

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.

HNA Device Classification - Class 1, General Controls

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.