Cleared Traditional

K070732 - BCI AUTOCON 3304 DIGITAL PULSE OXIMETER

K070732 is an FDA 510(k) clearance for BCI AUTOCON 3304 DIGITAL PULSE OXIMETER, manufactured by Smiths Medical Pm, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K070732 · Smiths Medical Pm, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
116d
Days
Class 2
Risk

K070732 is an FDA 510(k) clearance for the BCI AUTOCON 3304 DIGITAL PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Smiths Medical Pm, Inc. (Waukesha, US). The FDA issued a Cleared decision on July 9, 2007 after a review of 116 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 Smiths Medical Pm, Inc. devices

FDA 510(k) Submission Details - K070732

510(k) Number K070732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2007
Decision Date July 09, 2007
Days to Decision 116 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
24d faster than avg
Panel avg: 140d · This submission: 116d
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 478
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K070732.
FINGERTIP PULSE OXIMETER MD300C
K070371 · Beijing Choice Electronic Technololgy Co., Ltd. · Aug 2007
DIGITAL PULSE OXIMETER, MODEL 7500FO
K071415 · Nonin Medical, Inc. · Aug 2007
DIGITAL PULSE OXIMETER, MODEL 7500
K071285 · Nonin Medical, Inc. · Jul 2007
MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS
K071024 · Masimo Corporation · Jun 2007
DURAMAX REUSABLE OXIMETRY SENSOR
K070408 · Nellcor Puritan Bennett, Inc. · May 2007
LIFESENSE, MODEL LS1-9R
K063752 · Nonin Medical, Inc. · May 2007