Cleared Traditional

NEWOX2 (K945754) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K945754 · Bci Intl., Inc. · Anesthesiology device
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Jul 1995
Decision
236d
Days
Class 2
Risk

K945754 is an FDA 510(k) clearance for the NEWOX2. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Bci Intl., Inc. (Waukesha, US). The FDA issued a Cleared decision on July 17, 1995 after a review of 236 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 Bci Intl., Inc. devices

Submission Details

510(k) Number K945754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1994
Decision Date July 17, 1995
Days to Decision 236 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 140d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 190
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K945754.
VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)
K964978 · Quinton, Inc. · May 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
K970368 · Siemens Medical Solutions USA, Inc. · May 1997
OHMEDA 3800 PULSE OXIMETER
K962127 · Ohmeda Medical · Oct 1996
HP M1722A/B AND M1723A/B CODEMASTER
K944608 · Hewlett-Packard Co. · Oct 1994
OHMEDA HAND HELD OXIMETER
K931304 · Ohmeda Medical · Sep 1994
HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER
K923343 · Hewlett-Packard Co. · Feb 1993