Cleared Traditional

K013387 - DATEX-OHMEDA S/5 WEB VIEWER

K013387 is an FDA 510(k) clearance for DATEX-OHMEDA S/5 WEB VIEWER, manufactured by Datex-Ohmeda. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K013387 · Datex-Ohmeda · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
88d
Days
Class 2
Risk

K013387 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 WEB VIEWER. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on January 8, 2002 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight 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 Datex-Ohmeda devices

FDA 510(k) Submission Details - K013387

510(k) Number K013387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2001
Decision Date January 08, 2002
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSX Device Classification - Class 2, Special Controls

Product Code MSX System, Network And Communication, Physiological Monitors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - MSX System, Network And Communication, Physiological Monitors

All 73
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K013387.
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02
K022507 · Datex-Ohmeda · Aug 2002
UNITY IS PATIENT VIEWER
K020661 · General Electric Medical Systems Information Techn · May 2002
PATIENTNET MONITORING SYSTEM
K020524 · General Electric Medical Systems Information Techn · Mar 2002
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01
K013246 · Datex-Ohmeda · Dec 2001
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX
K012531 · Datex-Ohmeda · Nov 2001
DATEX-OHMEDA NETWORK AND CENTRAL
K000647 · Datex-Ohmeda, Inc. · Jul 2000