Cleared Traditional

K011156 - BCI 3403 SLEEP SCREENING PULSE OXIMETER

K011156 is an FDA 510(k) clearance for BCI 3403 SLEEP SCREENING PULSE OXIMETER, manufactured by Bci, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K011156 · Bci, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
59d
Days
Class 2
Risk

K011156 is an FDA 510(k) clearance for the BCI 3403 SLEEP SCREENING PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Bci, Inc. (Waukesha, US). The FDA issued a Cleared decision on June 14, 2001 after a review of 59 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, Inc. devices

FDA 510(k) Submission Details - K011156

510(k) Number K011156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2001
Decision Date June 14, 2001
Days to Decision 59 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
81d faster than avg
Panel avg: 140d · This submission: 59d
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 553
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K011156.
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
K011320 · Hitachi Medical Systems America, Inc. · Aug 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K011851 · Masimo Corp. · Jul 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE
K011670 · Datex-Ohmeda · Jun 2001
MEDLEY SP02 MODULE, MODEL 8220
K010966 · Alaris Medical Systems, Inc. · Jun 2001
NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
K010451 · Novametrix Medical Systems, Inc. · Apr 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
K010463 · Datex-Ohmeda, Inc. · Mar 2001