Cleared Traditional

K961450 - SCORE SOFTWARE

K961450 is an FDA 510(k) clearance for SCORE SOFTWARE, manufactured by Nellcor Puritan Bennett, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K961450 · Nellcor Puritan Bennett, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
108d
Days
Class 2
Risk

K961450 is an FDA 510(k) clearance for the SCORE SOFTWARE. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nellcor Puritan Bennett, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on August 1, 1996 after a review of 108 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 Nellcor Puritan Bennett, Inc. devices

FDA 510(k) Submission Details - K961450

510(k) Number K961450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1996
Decision Date August 01, 1996
Days to Decision 108 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
32d faster than avg
Panel avg: 140d · This submission: 108d
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 665
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K961450.
OHMEDA 3800 PULSE OXIMETER
K962127 · Ohmeda Medical · Oct 1996
E100A PULSE OXIMETER FINGER SENSOR/PROBE
K954168 · Epic Medical Equipment Services, Inc. · Sep 1996
3304 PULSE OXIMETER
K962156 · Bci Intl., Inc. · Aug 1996
SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)
K960614 · Somanetics Corp. · Jun 1996
OXITEMP, 3301T SA
K960058 · Bci Intl., Inc. · May 1996
BURDICK 200 PULSE OXIMETER
K954267 · Burdick, Inc. · May 1996