Cleared Traditional

K920966 - SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT)

K920966 is an FDA 510(k) clearance for SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT), 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 501-day FDA review.

K920966 · Aristo Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K920966

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.

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 K920966.
OXISAT
K934091 · Marquette Electronics, Inc. · Mar 1994
NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS
K940463 · Nonin Medical, Inc. · Mar 1994
NOVAMETRIX MODEL 510
K924626 · Novametrix Medical Systems, Inc. · Dec 1993
NELLCOR PORTABLE PULSE OXIMETER MODEL N-20
K915699 · Nellcor, Inc. · May 1993
9293/1 INTERFACE MODULE
K923418 · S & W Medico Teknik · Feb 1993
OXYSHUTTLE II ,MODIFICATION
K925542 · Sensor Medics Corp. · Feb 1993