Cleared Traditional

K963707 - NELLCOR PURITAN BENNETT NPB-40 HANDHELD...

K963707 is an FDA 510(k) clearance for NELLCOR PURITAN BENNETT NPB-40 HANDHELD..., 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 88-day FDA review.

K963707 · Nellcor Puritan Bennett, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Dec 1996
Decision
88d
Days
Class 2
Risk

K963707 is an FDA 510(k) clearance for the NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nellcor Puritan Bennett, Inc. (Pleasanton, US). The FDA issued a Cleared decision on December 13, 1996 after a review of 88 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 Nellcor Puritan Bennett, Inc. devices

FDA 510(k) Submission Details - K963707

510(k) Number K963707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date December 13, 1996
Days to Decision 88 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
52d faster than avg
Panel avg: 140d · This submission: 88d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K963707.
SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
K970368 · Siemens Medical Solutions USA, Inc. · May 1997
8500A PULSE OXIMETER
K945290 · Nonin Medical, Inc. · Feb 1997
MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES
K962603 · Masimo Corp. · Feb 1997
OHMEDA 3800 PULSE OXIMETER
K962127 · Ohmeda Medical · Oct 1996
SCORE SOFTWARE
K961450 · Nellcor Puritan Bennett, Inc. · Aug 1996
9267 SPO2 ATHENA MODULE
K940933 · S & W Medico Teknik · Nov 1995