Cleared Traditional

K881055 - ECG MONITOR AND RESPIRATION PACER

K881055 is an FDA 510(k) clearance for ECG MONITOR AND RESPIRATION PACER, manufactured by D. E. Hokanson, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K881055

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
Combination Product No
PCCP Authorized No
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.

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 426
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
MODEL 375 ECG
K881328 · Birtcher Corp. · May 1988