Cleared Traditional

K001842 - ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100

K001842 is an FDA 510(k) clearance for ADULT/PEDIATRIC CEREBRAL OXIMETER, manufactured by Somanetics Corp.. 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.

K001842 · Somanetics Corp. · Anesthesiology device
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Sep 2000
Decision
88d
Days
Class 2
Risk

K001842 is an FDA 510(k) clearance for the ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Somanetics Corp. (Troy, US). The FDA issued a Cleared decision on September 15, 2000 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 Somanetics Corp. devices

FDA 510(k) Submission Details - K001842

510(k) Number K001842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2000
Decision Date September 15, 2000
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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 511
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K001842.
MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500
K002690 · Nonin Medical, Inc. · Oct 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER
K002939 · Masimo Corp. · Oct 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K002751 · Masimo Corp. · Oct 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K002682 · Masimo Corp. · Sep 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K002477 · Masimo Corp. · Sep 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT
K002574 · Masimo Corp. · Sep 2000