Cleared Traditional

K030930 - OXIMAX SOFTCARE SENSORS

K030930 is an FDA 510(k) clearance for OXIMAX SOFTCARE SENSORS, 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 59-day FDA review.

K030930 · Nellcor Puritan Bennett, Inc. · Anesthesiology device
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May 2003
Decision
59d
Days
Class 2
Risk

K030930 is an FDA 510(k) clearance for the OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N. 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 May 23, 2003 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 Nellcor Puritan Bennett, Inc. devices

FDA 510(k) Submission Details - K030930

510(k) Number K030930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2003
Decision Date May 23, 2003
Days to Decision 59 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
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K030930.
MODEL 9600, AVANT PULSE OXIMETER
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MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K031330 · Masimo Corp. · May 2003
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
K021955 · Datex-Ohmeda, Inc. · Oct 2002
ATLAS MONITOR, MODELS 200,210,220
K022084 · Welch Allyn, Inc. · Sep 2002