Cleared Traditional

K811341 - BIOVISION CARDIAC STROBE

K811341 is an FDA 510(k) clearance for BIOVISION CARDIAC STROBE, manufactured by Cardiac Imaging. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K811341 · Cardiac Imaging · Cardiovascular device
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Jul 1981
Decision
65d
Days
Class 2
Risk

K811341 is an FDA 510(k) clearance for the BIOVISION CARDIAC STROBE. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cardiac Imaging (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981 after a review of 65 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 Cardiac Imaging devices

FDA 510(k) Submission Details - K811341

510(k) Number K811341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1981
Decision Date July 16, 1981
Days to Decision 65 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 125d · This submission: 65d
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 464
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K811341.
FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-36
K813021 · Brentwood Instruments, Inc. · Dec 1981
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
LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM
K810154 · Physio-Control Corp. · Mar 1981
STRESS TEST SYSTEM
K810357 · Nihon Kohden America, Inc. · Mar 1981