Cleared Traditional

K881055 - ECG MONITOR AND RESPIRATION PACER

K881055 is the FDA 510(k) clearance for ECG MONITOR AND RESPIRATION PACER by D. E. Hokanson, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K881055 · D. E. Hokanson, Inc. · Cardiovascular device
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Aug 1988
Decision
164d
Days
Class 2
Risk

K881055 is an FDA 510(k) clearance for the ECG MONITOR AND RESPIRATION PACER. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by D. E. Hokanson, Inc. (Issaquah, US). The FDA issued a Cleared decision on August 19, 1988 after a review of 164 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 D. E. Hokanson, Inc. devices

Submission Details

510(k) Number K881055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1988
Decision Date August 19, 1988
Days to Decision 164 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 125d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 264
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K881055.
CARDIOCAP(TM) CTO-104 MONITOR
K884956 · Datex Division Instrumentarium Corp. · Dec 1988
SYSTEM VI MONITOR
K874326 · Air-Shields, Inc. · Dec 1988
OEC-7102 ECG/NIBP MONITOR
K882254 · Nihon Kohden America, Inc. · Nov 1988
MINIMON 7131B PATIENT MONITOR
K882197 · Kontron Instruments, Inc. · Aug 1988
MINIMON 7132B PATIENT MONITOR
K882198 · Kontron Instruments, Inc. · Jul 1988
HORIZON 2000/S 266-XXX-XXX
K880595 · Mennen Medical, Inc. · May 1988