Cleared Traditional

K960251 - COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR

K960251 is an FDA 510(k) clearance for COMSAT ADULT, 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 68-day FDA review.

K960251 · Aristo Medical Products, Inc. · Anesthesiology device
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Mar 1996
Decision
68d
Days
Class 2
Risk

K960251 is an FDA 510(k) clearance for the COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE .... 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 March 26, 1996 after a review of 68 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aristo Medical Products, Inc. devices

FDA 510(k) Submission Details - K960251

510(k) Number K960251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1996
Decision Date March 26, 1996
Days to Decision 68 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
72d faster than avg
Panel avg: 140d · This submission: 68d
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 539
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K960251.
SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)
K960614 · Somanetics Corp. · Jun 1996
OXITEMP, 3301T SA
K960058 · Bci Intl., Inc. · May 1996
BURDICK 200 PULSE OXIMETER
K954267 · Burdick, Inc. · May 1996
9267 SPO2 ATHENA MODULE
K940933 · S & W Medico Teknik · Nov 1995
OXILINK (SMALL, MEDIUM, LARGE)
K953126 · Bci Intl., Inc. · Sep 1995
NELLCOR SYMPHONY N-3000 PULSE OXIMETER
K952316 · Nellcor, Inc. · Aug 1995