Cleared Traditional

K810154 - LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM

K810154 is an FDA 510(k) clearance for LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM, manufactured by Physio-Control Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K810154 · Physio-Control Corp. · Cardiovascular device
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Mar 1981
Decision
64d
Days
Class 2
Risk

K810154 is an FDA 510(k) clearance for the LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Physio-Control Corp. (Mchenry, US). The FDA issued a Cleared decision on March 26, 1981 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Physio-Control Corp. devices

FDA 510(k) Submission Details - K810154

510(k) Number K810154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1981
Decision Date March 26, 1981
Days to Decision 64 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
61d faster than avg
Panel avg: 125d · This submission: 64d
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 304
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K810154.
ELECTROCARDIOGRAPH CM3000
K813279 · Philips Medical Systems (Cleveland), Inc. · Dec 1981
FUKUDA DENSHI CARDIMAX FK-12
K813022 · Brentwood Instruments, Inc. · Dec 1981
PHYSIOLOGIC RECORDER
K810696 · Honeywell, Inc. · Mar 1981
STRESS TEST SYSTEM
K810357 · Nihon Kohden America, Inc. · Mar 1981
OPTION 301 PACEMAKER EVAL. MODULE MAC-1
K802368 · Marquette Electronics, Inc. · Mar 1981
ECG FUNCTION BLOCK
K810176 · Honeywell, Inc. · Feb 1981