Cleared Traditional

K812646 - SKI 5000

K812646 is the FDA 510(k) clearance for SKI 5000 by Smithkline Diagnostics, Inc.. It is a Class 2 Cardiovascular device (product code DXK) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K812646 · Smithkline Diagnostics, Inc. · Cardiovascular device
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Nov 1981
Decision
60d
Days
Class 2
Risk

K812646 is an FDA 510(k) clearance for the SKI 5000. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Smithkline Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - 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 Smithkline Diagnostics, Inc. devices

Submission Details

510(k) Number K812646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1981
Decision Date November 16, 1981
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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 - DXK Echocardiograph

All 35
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K812646.
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM
K852543 · Kontron Instruments, Inc. · Sep 1985
DEL MAR AVIONICS 8300 SECTOR IMAGER SYS
K844896 · Del Mar Avionics · Jun 1985
MAVIS C
K813002 · Philips Medical Systems (Cleveland), Inc. · Mar 1982
DC-1 CARDIAC IMAGING MODULE
K811556 · Diasonics, Inc. · Jul 1981
MARK III ULTRASONIC SCANNING SYSTEM
K802917 · Advanced Technology Laboratories, Inc. · Jan 1981
CONTIUOUS WAVE DOPPLER ULTRASOUND
K802670 · American Edwards Laboratories · Nov 1980