Cleared Traditional

K953817 - ARISTO MEDICAL MODEL 2101 PATIENT MONITOR

K953817 is an FDA 510(k) clearance for ARISTO MEDICAL MODEL 2101 PATIENT MONITOR, manufactured by Aristo Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K953817 · Aristo Medical Products, Inc. · Anesthesiology device
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Nov 1995
Decision
100d
Days
Class 2
Risk

K953817 is an FDA 510(k) clearance for the ARISTO MEDICAL MODEL 2101 PATIENT MONITOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Aristo Medical Products, Inc. (Waukesha, US). The FDA issued a Cleared decision on November 22, 1995 after a review of 100 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 Aristo Medical Products, Inc. devices

FDA 510(k) Submission Details - K953817

510(k) Number K953817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1995
Decision Date November 22, 1995
Days to Decision 100 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 140d · This submission: 100d
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 540
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K953817.
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K952316 · Nellcor, Inc. · Aug 1995
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