Cleared Traditional

SPACELABS-GENERAL SYSTEM LINK (K850627) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

Device Classification

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 184
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K850627.
MICOR
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QUINTON Q.CATH
K862740 · Quinton, Inc. · Oct 1986
SIRECUST 425, RESPECTIVELY SIRECUST 430
K851637 · Siemens Medical Solutions USA, Inc. · Jul 1985
Q3000
K834567 · Quinton, Inc. · Apr 1984
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE
K810750 · General Electric Co. · Mar 1981
QUINTON STATUS 1000
K782072 · Quinton, Inc. · Feb 1979