Cleared Traditional

K934091 - OXISAT

K934091 is an FDA 510(k) clearance for OXISAT, manufactured by Marquette Electronics, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K934091 · Marquette Electronics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
204d
Days
Class 2
Risk

K934091 is an FDA 510(k) clearance for the OXISAT. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Jupiter, US). The FDA issued a Cleared decision on March 15, 1994 after a review of 204 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 Marquette Electronics, Inc. devices

FDA 510(k) Submission Details - K934091

510(k) Number K934091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1993
Decision Date March 15, 1994
Days to Decision 204 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 140d · This submission: 204d
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 628
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K934091.
PULSE OXIMETER
K941289 · Bci Intl., Inc. · Jun 1994
BIOCHEM MODEL 3302 NEWOX2 OXIMETER
K920083 · Biochem International, Inc. · Apr 1994
FUKUDA DENSHI MODEL HG-301
K921454 · Fukuda Denshi USA, Inc. · Apr 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