Cleared Traditional

K945754 - NEWOX2

K945754 is an FDA 510(k) clearance for NEWOX2, manufactured by Bci Intl., Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K945754 · Bci Intl., Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K945754

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
Combination Product No
PCCP Authorized No
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.

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 686
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K945754.
OXILINK (SMALL, MEDIUM, LARGE)
K953126 · Bci Intl., Inc. · Sep 1995
NELLCOR SYMPHONY N-3000 PULSE OXIMETER
K952316 · Nellcor, Inc. · Aug 1995
NELLCOR N-20PA PORTABLE PULSE OXIMETER
K952222 · Nellcor, Inc. · Aug 1995
NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000
K942347 · Nellcor, Inc. · May 1995
3301T OXITEMP
K946185 · Bci Intl., Inc. · Mar 1995
HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE
K942842 · Hewlett-Packard GmbH · Feb 1995