Cleared Traditional

K946185 - 3301T OXITEMP

K946185 is an FDA 510(k) clearance for 3301T OXITEMP, 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 87-day FDA review.

K946185 · Bci Intl., Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
87d
Days
Class 2
Risk

K946185 is an FDA 510(k) clearance for the 3301T OXITEMP. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Bci Intl., Inc. (Waukesha, US). The FDA issued a Cleared decision on March 17, 1995 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bci Intl., Inc. devices

FDA 510(k) Submission Details - K946185

510(k) Number K946185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1994
Decision Date March 17, 1995
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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 476
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K946185.
9267 SPO2 ATHENA MODULE
K940933 · S & W Medico Teknik · Nov 1995
OXILINK (SMALL, MEDIUM, LARGE)
K953126 · Bci Intl., Inc. · Sep 1995
NEWOX2
K945754 · Bci Intl., Inc. · Jul 1995
FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE
K945464 · Fukuda Denshi USA, Inc. · Feb 1995
MINIATURIZED FINGER CLIP PULSE OXIMETER
K942248 · Nonin Medical, Inc. · Dec 1994
MARQUETTE ADULT/NEONATAL WRAP SENSOR
K943817 · Marquette Electronics, Inc. · Oct 1994