Cleared Traditional

K011365 - VITALSAT PULSE OXIMETER, MODEL IC32000

K011365 is an FDA 510(k) clearance for VITALSAT PULSE OXIMETER, manufactured by Island Critical Care Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K011365 · Island Critical Care Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
175d
Days
Class 2
Risk

K011365 is an FDA 510(k) clearance for the VITALSAT PULSE OXIMETER, MODEL IC32000. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Island Critical Care Corp. (Stratford, P.E.I., CA). The FDA issued a Cleared decision on October 26, 2001 after a review of 175 days - an extended review 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: 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 Island Critical Care Corp. devices

FDA 510(k) Submission Details - K011365

510(k) Number K011365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2001
Decision Date October 26, 2001
Days to Decision 175 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
35d slower than avg
Panel avg: 140d · This submission: 175d
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 565
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K011365.
NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR
K013319 · Nonin Medical, Inc. · Jan 2002
FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE
K013273 · Fukuda Denshi USA, Inc. · Dec 2001
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K013792 · Masimo Corp. · Dec 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES
K012992 · Masimo Corp. · Oct 2001
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
K011320 · Hitachi Medical Systems America, Inc. · Aug 2001
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K011851 · Masimo Corp. · Jul 2001