Cleared Traditional

K960058 - OXITEMP

K960058 is an FDA 510(k) clearance for 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 134-day FDA review.

K960058 · Bci Intl., Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
134d
Days
Class 2
Risk

K960058 is an FDA 510(k) clearance for the OXITEMP, 3301T SA. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Bci Intl., Inc. (Waukesha, US). The FDA issued a Cleared decision on May 15, 1996 after a review of 134 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 Bci Intl., Inc. devices

FDA 510(k) Submission Details - K960058

510(k) Number K960058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1996
Decision Date May 15, 1996
Days to Decision 134 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
6d faster than avg
Panel avg: 140d · This submission: 134d
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 K960058.
OHMEDA 3800 PULSE OXIMETER
K962127 · Ohmeda Medical · Oct 1996
3304 PULSE OXIMETER
K962156 · Bci Intl., Inc. · Aug 1996
SCORE SOFTWARE
K961450 · Nellcor Puritan Bennett, Inc. · Aug 1996
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