Cleared Traditional

K885058 - CARDIOCAP(TM) DR-104 REPORTER

K885058 is an FDA 510(k) clearance for CARDIOCAP(TM) DR-104 REPORTER, manufactured by Datex Division Instrumentarium Corp.. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K885058 · Datex Division Instrumentarium Corp. · Cardiovascular device
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Jul 1989
Decision
219d
Days
Class 1
Risk

K885058 is an FDA 510(k) clearance for the CARDIOCAP(TM) DR-104 REPORTER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on July 14, 1989 after a review of 219 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 Datex Division Instrumentarium Corp. devices

FDA 510(k) Submission Details - K885058

510(k) Number K885058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1988
Decision Date July 14, 1989
Days to Decision 219 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
94d slower than avg
Panel avg: 125d · This submission: 219d
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 K885058.
COLORADO COLOR IMAGING RECORDER
K902230 · Honeywell, Inc. · Jun 1990
TYPE 9541 RECORDER, PAPER CHART
K895111 · S & W Medico Teknik · Jan 1990
EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.
K893561 · Edentec Corp. · Aug 1989
FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
K884897 · Mennen Medical, Inc. · Mar 1989
EDENTEC MODEL 4700 SCANNER
K884388 · Edentec Corp. · Jan 1989
EDENTRACE MULTI-CHARTER MODEL 3700
K883315 · Edentec Corp. · Dec 1988