Cleared Traditional

K022274 - CARECOMPANION PATIENT STATION & NURSE S...

K022274 is the FDA 510(k) clearance for CARECOMPANION PATIENT STATION & NURSE S... by Neptec Design Group, Ltd.. It is a Class 2 Cardiovascular device (product code DRG) cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K022274 · Neptec Design Group, Ltd. · Cardiovascular device
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May 2003
Decision
318d
Days
Class 2
Risk

K022274 is an FDA 510(k) clearance for the CARECOMPANION PATIENT STATION & NURSE STATION. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Neptec Design Group, Ltd. (Kanata, Ontario, CA). The FDA issued a Cleared decision on May 29, 2003 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Neptec Design Group, Ltd. devices

Submission Details

510(k) Number K022274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2002
Decision Date May 29, 2003
Days to Decision 318 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 125d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 72
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