Cleared Traditional

K983448 - ML UNIVERSAL TUBING

K983448 is an FDA 510(k) clearance for ML UNIVERSAL TUBING, manufactured by Med-Logics, Inc.. The device is a Class 2 Ophthalmic device with product code MSR cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K983448 · Med-Logics, Inc. · Ophthalmic device
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Dec 1998
Decision
79d
Days
Class 2
Risk

K983448 is an FDA 510(k) clearance for the ML UNIVERSAL TUBING. Classified as Tubing, Replacement, Phacofragmentation Unit (product code MSR), Class II - Special Controls.

Submitted by Med-Logics, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on December 18, 1998 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Med-Logics, Inc. devices

FDA 510(k) Submission Details - K983448

510(k) Number K983448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1998
Decision Date December 18, 1998
Days to Decision 79 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 110d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSR Device Classification - Class 2, Special Controls

Product Code MSR Tubing, Replacement, Phacofragmentation Unit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
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.