Cleared Traditional

K811094 - CARDIAC 1000 TM

K811094 is an FDA 510(k) clearance for CARDIAC 1000 TM, manufactured by American Edwards Laboratories. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K811094 · American Edwards Laboratories · Radiology device
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Jul 1981
Decision
98d
Days
Class 2
Risk

K811094 is an FDA 510(k) clearance for the CARDIAC 1000 TM. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on July 28, 1981 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Edwards Laboratories devices

FDA 510(k) Submission Details - K811094

510(k) Number K811094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1981
Decision Date July 28, 1981
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 Radiology devices follow this clearance model.

Regulatory Peers - JAA System, X-ray, Fluoroscopic, Image-intensified

All 186
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K811094.
IBIS II
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FLUORICON L300 IMAGE INTENSIFIER
K812775 · General Electric Co. · Nov 1981
LATERAL ANGULATING FLUORO SUSPENSION SYS
K812561 · General Electric Co. · Oct 1981
DIGITAL NOISE REDUCER
K811295 · Philips Medical Systems (Cleveland), Inc. · Jun 1981
DIGITAL RADIOGRAPHY SYSTEM
K810364 · Adac Laboratories · Mar 1981
SIRECON COMPACT
K810189 · Siemens Corp. · Mar 1981