Cleared Traditional

K943456 - AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT

K943456 is an FDA 510(k) clearance for AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, 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 91-day FDA review.

K943456 · Datex Division Instrumentarium Corp. · Anesthesiology device
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Oct 1994
Decision
91d
Days
Class 2
Risk

K943456 is an FDA 510(k) clearance for the AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, FI). The FDA issued a Cleared decision on October 17, 1994 after a review of 91 days - within the typical 510(k) review window.

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 - K943456

510(k) Number K943456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1994
Decision Date October 17, 1994
Days to Decision 91 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
49d faster than avg
Panel avg: 140d · This submission: 91d
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 K943456.
FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE
K945464 · Fukuda Denshi USA, Inc. · Feb 1995
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K942248 · Nonin Medical, Inc. · Dec 1994
MARQUETTE ADULT/NEONATAL WRAP SENSOR
K943817 · Marquette Electronics, Inc. · Oct 1994
BURDICK PRO2 OXIMETER
K941351 · Burdick Corp. · Oct 1994
3301 PULSE OXIMETER
K943404 · Bci Intl., Inc. · Oct 1994
HP M1722A/B AND M1723A/B CODEMASTER
K944608 · Hewlett-Packard Co. · Oct 1994