Cleared Traditional

K051940 - CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA

K051940 is an FDA 510(k) clearance for CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA, manufactured by Sis Ltd., Surgical Instrument Systems. The device is a Class 2 Ophthalmic device with product code MXK cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K051940 · Sis Ltd., Surgical Instrument Systems · Ophthalmic device
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Sep 2005
Decision
72d
Days
Class 2
Risk

K051940 is an FDA 510(k) clearance for the CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA. Classified as Device, Analysis, Anterior Segment (product code MXK), Class II - Special Controls.

Submitted by Sis Ltd., Surgical Instrument Systems (Littleton, US). The FDA issued a Cleared decision on September 28, 2005 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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 Sis Ltd., Surgical Instrument Systems devices

FDA 510(k) Submission Details - K051940

510(k) Number K051940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2005
Decision Date September 28, 2005
Days to Decision 72 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 110d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXK Device Classification - Class 2, Special Controls

Product Code MXK Device, Analysis, Anterior Segment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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.