Cleared Special

K982635 - CAREDOP II

K982635 is an FDA 510(k) clearance for CAREDOP II, manufactured by Nicolet Biomedical. The device is a Class 2 Radiology device with product code JAF cleared through the Special 510(k) pathway after a 25-day FDA review.

K982635 · Nicolet Biomedical · Radiology device
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Aug 1998
Decision
25d
Days
Class 2
Risk

K982635 is an FDA 510(k) clearance for the CAREDOP II. Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Nicolet Biomedical (Golden, US). The FDA issued a Cleared decision on August 7, 1998 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1540 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nicolet Biomedical devices

FDA 510(k) Submission Details - K982635

510(k) Number K982635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1998
Decision Date August 07, 1998
Days to Decision 25 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

JAF Device Classification - Class 2, Special Controls

Product Code JAF Monitor, Ultrasonic, Nonfetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1540
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 Radiology devices follow this clearance model.

Regulatory Peers - JAF Monitor, Ultrasonic, Nonfetal

All 7
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