Cleared Traditional

K920966 - SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (...

K920966 is the FDA 510(k) clearance for SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (... by Aristo Medical Products, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 501-day FDA review.

K920966 · Aristo Medical Products, Inc. · Anesthesiology device
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Jul 1993
Decision
501d
Days
Class 2
Risk

K920966 is an FDA 510(k) clearance for the SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT). 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 July 16, 1993 after a review of 501 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Aristo Medical Products, Inc. devices

Submission Details

510(k) Number K920966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1992
Decision Date July 16, 1993
Days to Decision 501 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
361d slower than avg
Panel avg: 140d · This submission: 501d
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 K920966.
HP M1722A/B AND M1723A/B CODEMASTER
K944608 · Hewlett-Packard Co. · Oct 1994
OHMEDA HAND HELD OXIMETER
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OXISAT
K934091 · Marquette Electronics, Inc. · Mar 1994
HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER
K923343 · Hewlett-Packard Co. · Feb 1993
MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
K923682 · Hewlett-Packard Co. · Sep 1992
CIBA CORNING MODEL 270 CO-OXIMETER
K913332 · Ciba Corning Diagnostics Corp. · Oct 1991