Cleared Special

K021246 - SENSAID, MODELS# RC-NVA30-10

Also marketed or referenced as:
RC-CS140-10 RC-BC150-3

K021246 is an FDA 510(k) clearance for SENSAID, manufactured by Sensidyne, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 24-day FDA review.

K021246 · Sensidyne, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
24d
Days
Class 2
Risk

K021246 is an FDA 510(k) clearance for the SENSAID, MODELS# RC-NVA30-10. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Sensidyne, Inc. (Clearwater, US). The FDA issued a Cleared decision on May 13, 2002 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device 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 Sensidyne, Inc. devices

FDA 510(k) Submission Details - K021246

510(k) Number K021246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2002
Decision Date May 13, 2002
Days to Decision 24 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 140d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 561
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