Cleared Traditional

K974253 - CPD COMMANDER

K974253 is an FDA 510(k) clearance for CPD COMMANDER, manufactured by Scieran Technologies, Inc.. The device is a Class 2 Ophthalmic device with product code MRH cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K974253 · Scieran Technologies, Inc. · Ophthalmic device
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Feb 1998
Decision
104d
Days
Class 2
Risk

K974253 is an FDA 510(k) clearance for the CPD COMMANDER. Classified as Pump, Infusion, Ophthalmic (product code MRH), Class II - Special Controls.

Submitted by Scieran Technologies, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on February 25, 1998 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 880.5725 - 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 Scieran Technologies, Inc. devices

FDA 510(k) Submission Details - K974253

510(k) Number K974253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1997
Decision Date February 25, 1998
Days to Decision 104 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
6d faster than avg
Panel avg: 110d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRH Device Classification - Class 2, Special Controls

Product Code MRH Pump, Infusion, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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.

Regulatory Peers - MRH Pump, Infusion, Ophthalmic

All 12
Devices cleared under the same product code (MRH) and FDA review panel - the closest regulatory comparables to K974253.
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K972664 · Storz Instrument Co. · Oct 1997
DIGI-INJECTOR
K971067 · Medical Instrument Development Laboratories, Inc. · Sep 1997