Cleared Traditional

K904355 - CARDIOCAP II TM CH-RESP MONITORS

K904355 is an FDA 510(k) clearance for CARDIOCAP II TM CH-RESP MONITORS, manufactured by Instrumentarium Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K904355 · Instrumentarium Corp. · Cardiovascular device
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May 1991
Decision
241d
Days
Class 2
Risk

K904355 is an FDA 510(k) clearance for the CARDIOCAP II TM CH-RESP MONITORS. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Instrumentarium Corp. (Finland, FI). The FDA issued a Cleared decision on May 23, 1991 after a review of 241 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Instrumentarium Corp. devices

FDA 510(k) Submission Details - K904355

510(k) Number K904355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1990
Decision Date May 23, 1991
Days to Decision 241 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
116d slower than avg
Panel avg: 125d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 429
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K904355.
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COORDINATOR, CABLE INPUT
K914725 · Cardiotronics, Inc. · Nov 1991
HORIZON 2000 ST ANALYSIS OPTION
K903524 · Mennen Medical, Inc. · Mar 1991
MODEL 405
K904606 · Ivy Biomedical Systems, Inc. · Mar 1991
CARDIOFAX ECG-8830A
K904758 · Nihon Kohden America, Inc. · Dec 1990