Cleared Traditional

K895111 - TYPE 9541 RECORDER, PAPER CHART

K895111 is an FDA 510(k) clearance for TYPE 9541 RECORDER, manufactured by S & W Medico Teknik. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K895111 · S & W Medico Teknik · Cardiovascular device
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Jan 1990
Decision
176d
Days
Class 1
Risk

K895111 is an FDA 510(k) clearance for the TYPE 9541 RECORDER, PAPER CHART. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on January 26, 1990 after a review of 176 days - an extended review 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: 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 S & W Medico Teknik devices

FDA 510(k) Submission Details - K895111

510(k) Number K895111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1989
Decision Date January 26, 1990
Days to Decision 176 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
51d slower than avg
Panel avg: 125d · This submission: 176d
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 56
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K895111.
EDENTEC DIGITAL CHARTER MODEL 3710
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CARDIOCAP(TM) DR-104 REPORTER
K885058 · Datex Division Instrumentarium Corp. · Jul 1989
FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
K884897 · Mennen Medical, Inc. · Mar 1989