Cleared Traditional

K962811 - SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION

K962811 is an FDA 510(k) clearance for SPACELABS MEDICAL MULTI-DISCLOSURE WORK..., manufactured by Spacelabs Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXJ cleared through the Traditional 510(k) pathway after a 341-day FDA review.

K962811 · Spacelabs Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
341d
Days
Class 2
Risk

K962811 is an FDA 510(k) clearance for the SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Spacelabs Medical, Inc. (Redmond, US). The FDA issued a Cleared decision on June 24, 1997 after a review of 341 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2450 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Spacelabs Medical, Inc. devices

FDA 510(k) Submission Details - K962811

510(k) Number K962811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1996
Decision Date June 24, 1997
Days to Decision 341 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
216d slower than avg
Panel avg: 125d · This submission: 341d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXJ Device Classification - Class 2, Special Controls

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
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 - DXJ Display, Cathode-ray Tube, Medical

All 65
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K962811.
GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC
K001112 · General Electric Medical Systems Information Techn · Jun 2000
HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
K992636 · Hewlett-Packard Co. · Aug 1999
ECG REVIEW STATION
K942685 · Mortara Instrument, Inc. · Aug 1997
HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR
K945277 · Hewlett-Packard Co. · Jan 1995
SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY
K932724 · Spacelabs Medical, Inc. · Nov 1993
MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM
K905788 · Hewlett-Packard Co. · Jun 1991