Cleared Traditional

K970769 - COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR

K970769 is an FDA 510(k) clearance for COMSAT ADULT, manufactured by Aristo Medical. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K970769 · Aristo Medical · Anesthesiology device
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Aug 1997
Decision
178d
Days
Class 2
Risk

K970769 is an FDA 510(k) clearance for the COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FING.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Aristo Medical (Waukesha, US). The FDA issued a Cleared decision on August 28, 1997 after a review of 178 days - an extended review cycle.

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 Aristo Medical devices

FDA 510(k) Submission Details - K970769

510(k) Number K970769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1997
Decision Date August 28, 1997
Days to Decision 178 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 140d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 548
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K970769.
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K971946 · Nellcor Puritan Bennett, Inc. · Aug 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764
K971827 · Alexander Mfg. Co. · Aug 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115
K971828 · Alexander Mfg. Co. · Aug 1997