Cleared Traditional

K811540 - SPACELABS' SYSTEM AUTORECORDER

K811540 is an FDA 510(k) clearance for SPACELABS' SYSTEM AUTORECORDER, manufactured by Spacelabs, Inc.. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K811540 · Spacelabs, Inc. · Cardiovascular device
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Aug 1981
Decision
73d
Days
Class 1
Risk

K811540 is an FDA 510(k) clearance for the SPACELABS' SYSTEM AUTORECORDER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Spacelabs, Inc. (Walker, US). The FDA issued a Cleared decision on August 13, 1981 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2810 - 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 Spacelabs, Inc. devices

FDA 510(k) Submission Details - K811540

510(k) Number K811540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1981
Decision Date August 13, 1981
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

DSF Device Classification - Class 1, General Controls

Product Code DSF Recorder, Paper Chart
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DSF Recorder, Paper Chart

All 50
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K811540.
CENTURION CHART RECORDER
K822432 · Clinical Data, Inc. · Nov 1982
MODEL 16800 TREND RECORDER
K821612 · Healthdyne, Inc. · Jul 1982
CARDIOVUE ACCESSORY CART
K820033 · Diasonics, Inc. · Jan 1982
PAPER CHART RECORDER
K811254 · American Edwards Laboratories · Jul 1981
NOVATRACER RECORDER
K811453 · Novametrix Medical Systems, Inc. · Jul 1981
1,2,3 CHANNELL RECORDERS (AR150,AR250,-)
K810166 · Honeywell, Inc. · Feb 1981