Cleared Traditional

K020350 - BCI 3180 PULSE OXIMETER

K020350 is an FDA 510(k) clearance for BCI 3180 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 85-day FDA review.

K020350 · Bci, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
85d
Days
Class 2
Risk

K020350 is an FDA 510(k) clearance for the BCI 3180 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 April 30, 2002 after a review of 85 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.

FDA 510(k) Submission Details - K020350

510(k) Number K020350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2002
Decision Date April 30, 2002
Days to Decision 85 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
55d faster than avg
Panel avg: 140d · This submission: 85d
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 726
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K020350.
BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR
K020739 · Bci, Inc. · Jun 2002
SENSAID, MODELS# RC-NVA30-10
K021246 · Sensidyne, Inc. · May 2002
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K021090 · Nellcor Puritan Bennett, Inc. · May 2002
HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER
K014025 · Hommed, LLC · Apr 2002
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES
K020479 · Datex-Ohmeda · Mar 2002
DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070
K012989 · Dolphin Medical, Inc. · Mar 2002
K020350 · BCI 3180 PULSE OXIMETER
Download PDF FDA Summary Bci, Inc.