Cleared Traditional

K801549 - MODEL R11 SINGLE CHANNEL CHART RECORDER

K801549 is an FDA 510(k) clearance for MODEL R11 SINGLE CHANNEL CHART RECORDER, manufactured by Medasonics, Inc.. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K801549 · Medasonics, Inc. · Cardiovascular device
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Jul 1980
Decision
7d
Days
Class 1
Risk

K801549 is an FDA 510(k) clearance for the MODEL R11 SINGLE CHANNEL CHART RECORDER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Medasonics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1980 after a review of 7 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 Medasonics, Inc. devices

FDA 510(k) Submission Details - K801549

510(k) Number K801549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1980
Decision Date July 14, 1980
Days to Decision 7 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 125d · This submission: 7d
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 51
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K801549.
CENTRAL STATION CONTROLLER AC100/CE100
K810169 · Honeywell, Inc. · Feb 1981
ADVANCEMED EXAMINER
K803225 · American Edwards Laboratories · Jan 1981
MODEL 9300 ELECTROCARDIOVALIDATOR
K801830 · Del Mar Avionics · Aug 1980
CRITIKON DUAL CHANNEL RECORDER
K792105 · Critikon Company, LLC · Oct 1979
LS-8 VISICORDER
K790825 · Honeywell, Inc. · May 1979
ECG PAPER, 3 CHANNEL
K780597 · Abco Dealers, Inc. · Jun 1978