Cleared Traditional

CVINSIGHT (K120052) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120052 · Intelomed, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
242d
Days
Class 2
Risk

K120052 is an FDA 510(k) clearance for the CVINSIGHT. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Intelomed, Inc. (Allison Park, US). The FDA issued a Cleared decision on September 4, 2012 after a review of 242 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 Intelomed, Inc. devices

Submission Details

510(k) Number K120052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2012
Decision Date September 04, 2012
Days to Decision 242 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
102d slower than avg
Panel avg: 140d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 207
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K120052.
BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
K121806 · Covidien · Sep 2012
MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS
K120657 · Masimo Corporation · Sep 2012
MASIMO SET USPO2 PULSE OXIMETRY CABLE
K121914 · Masimo Corporation · Sep 2012
E1 EAR SENSORS
K121912 · Masimo Corporation · Jul 2012
NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM
K120773 · Covidien, LLC · Jul 2012
VTRUST FINGER TYPE PULSE OXIMETER
K110893 · Taidoc Technology Corporation · Nov 2011