Cleared Traditional

K905140 - SATLITE PLUS PULSE OXIMETER

K905140 is an FDA 510(k) clearance for SATLITE PLUS PULSE OXIMETER, manufactured by Datex Division Instrumentarium Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K905140 · Datex Division Instrumentarium Corp. · Anesthesiology device
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May 1991
Decision
194d
Days
Class 2
Risk

K905140 is an FDA 510(k) clearance for the SATLITE PLUS PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on May 28, 1991 after a review of 194 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 Datex Division Instrumentarium Corp. devices

FDA 510(k) Submission Details - K905140

510(k) Number K905140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1990
Decision Date May 28, 1991
Days to Decision 194 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
54d slower than avg
Panel avg: 140d · This submission: 194d
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 502
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K905140.
CIBA CORNING MODEL 270 CO-OXIMETER
K913332 · Ciba Corning Diagnostics Corp. · Oct 1991
MODEL 8604-FO PULSE OXIMETER
K910001 · Nonin Medical, Inc. · Jul 1991
503 PULSE OXIMETER
K911124 · Criticare Systems, Inc. · Jun 1991
AP-860PA NIBP MODULE
K910629 · Nihon Kohden America, Inc. · May 1991
504US PULSE OXIMETER
K910770 · Criticare Systems, Inc. · May 1991
REFLECTANCE SENSOR (RS-10)
K904039 · Nellcor, Inc. · Dec 1990