Cleared Traditional

K992238 - MASIMO SET RADICAL PULSE OXIMETER

K992238 is an FDA 510(k) clearance for MASIMO SET RADICAL PULSE OXIMETER, manufactured by Masimo Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K992238 · Masimo Corp. · Anesthesiology device
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Oct 1999
Decision
98d
Days
Class 2
Risk

K992238 is an FDA 510(k) clearance for the MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT,.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Masimo Corp. (Irvine, US). The FDA issued a Cleared decision on October 8, 1999 after a review of 98 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 Masimo Corp. devices

FDA 510(k) Submission Details - K992238

510(k) Number K992238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1999
Decision Date October 08, 1999
Days to Decision 98 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
42d faster than avg
Panel avg: 140d · This submission: 98d
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 K992238.
SPACELABS MEDICAL DISPOSABLE SP02 SENSOR
K981655 · Spacelabs Medical, Inc. · Dec 1999
N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS
K993637 · Nellcor Puritan Bennett, Inc. · Nov 1999
MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES
K993555 · Masimo Corp. · Nov 1999
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE
K992340 · Masimo Corp. · Oct 1999
N-395 PULSE OXIMETER, MODEL N-395
K991823 · Nellcor Puritan Bennett, Inc. · Aug 1999
MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS
K990966 · Masimo Corp. · Jun 1999