Cleared Traditional

K892120 - ESCORT PULSE OXIMETRY OPTION

K892120 is an FDA 510(k) clearance for ESCORT PULSE OXIMETRY OPTION, manufactured by Medical Data Electronics. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K892120 · Medical Data Electronics · Anesthesiology device
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Sep 1989
Decision
179d
Days
Class 2
Risk

K892120 is an FDA 510(k) clearance for the ESCORT PULSE OXIMETRY OPTION. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on September 26, 1989 after a review of 179 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 Medical Data Electronics devices

FDA 510(k) Submission Details - K892120

510(k) Number K892120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1989
Decision Date September 26, 1989
Days to Decision 179 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 140d · This submission: 179d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K892120.
MODEL 90489 PULSE OXIMETER MODULE
K901209 · Spacelabs, Inc. · Apr 1990
MODEL 8500 HAND HELD PULSE OXIMETER
K893221 · Nonin Medical, Inc. · Feb 1990
NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER
K893643 · Novametrix Medical Systems, Inc. · Oct 1989
MINIMON 7137B PATIENT MONITOR
K895425 · Kontron Instruments, Inc. · Sep 1989
CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE
K893867 · Spacelabs, Inc. · Sep 1989
OXIMETER
K893587 · Radiometer America, Inc. · Sep 1989