Cleared Traditional

K962156 - 3304 PULSE OXIMETER

K962156 is an FDA 510(k) clearance for 3304 PULSE OXIMETER, 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 85-day FDA review.

K962156 · Bci Intl., Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
85d
Days
Class 2
Risk

K962156 is an FDA 510(k) clearance for the 3304 PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Bci Intl., Inc. (Waukesha, US). The FDA issued a Cleared decision on August 28, 1996 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.

View all Bci Intl., Inc. devices

FDA 510(k) Submission Details - K962156

510(k) Number K962156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1996
Decision Date August 28, 1996
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 476
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K962156.
NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)
K963707 · Nellcor Puritan Bennett, Inc. · Dec 1996
OXI TEMP
K963496 · Bci Intl., Inc. · Nov 1996
OHMEDA 3800 PULSE OXIMETER
K962127 · Ohmeda Medical · Oct 1996
SCORE SOFTWARE
K961450 · Nellcor Puritan Bennett, Inc. · Aug 1996
OXITEMP, 3301T SA
K960058 · Bci Intl., Inc. · May 1996
9267 SPO2 ATHENA MODULE
K940933 · S & W Medico Teknik · Nov 1995