Cleared Traditional

K850627 - SPACELABS-GENERAL SYSTEM LINK

K850627 is an FDA 510(k) clearance for SPACELABS-GENERAL SYSTEM LINK, manufactured by Spacelabs, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K850627 · Spacelabs, Inc. · Cardiovascular device
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May 1985
Decision
98d
Days
Class 2
Risk

K850627 is an FDA 510(k) clearance for the SPACELABS-GENERAL SYSTEM LINK. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Spacelabs, Inc. (Chatsworth, US). The FDA issued a Cleared decision on May 28, 1985 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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. Standard predicate reliance. 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, Inc. devices

FDA 510(k) Submission Details - K850627

510(k) Number K850627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1985
Decision Date May 28, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 269
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K850627.
QUINTON Q.CATH
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PDS 9000 PATIENT DATA MGMT. SYSTEM
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SIRECUST 425, RESPECTIVELY SIRECUST 430
K851637 · Siemens Medical Solutions USA, Inc. · Jul 1985
Q3000
K834567 · Quinton, Inc. · Apr 1984
KONTRON PMS 7000
K812354 · Kontron Instruments, Inc. · Sep 1981
MODEL IM1000 INTEGRATED MONITOR
K810731 · Gould, Inc. · Mar 1981