Cleared Traditional

K952327 - SMARTSAT PULSE OXIMETRY ANALYZER

K952327 is the FDA 510(k) clearance for SMARTSAT PULSE OXIMETRY ANALYZER by Clinical Dynamics Corp.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K952327 · Clinical Dynamics Corp. · Anesthesiology device
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Aug 1995
Decision
99d
Days
Class 2
Risk

K952327 is an FDA 510(k) clearance for the SMARTSAT PULSE OXIMETRY ANALYZER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Clinical Dynamics Corp. (Wallingford, US). The FDA issued a Cleared decision on August 25, 1995 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Clinical Dynamics Corp. devices

Submission Details

510(k) Number K952327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1995
Decision Date August 25, 1995
Days to Decision 99 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 140d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 249
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K952327.
VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)
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OHMEDA 3800 PULSE OXIMETER
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K943817 · Marquette Electronics, Inc. · Oct 1994
HP M1722A/B AND M1723A/B CODEMASTER
K944608 · Hewlett-Packard Co. · Oct 1994
OHMEDA HAND HELD OXIMETER
K931304 · Ohmeda Medical · Sep 1994