Cleared Traditional

HEART - AID ALS, 95 (K841556) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K841556 · Cardiac Resucitator Corp. · Toxicology device
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Jul 1984
Decision
94d
Days
Class 2
Risk

K841556 is an FDA 510(k) clearance for the HEART - AID ALS, 95. Classified as Enzymatic Radiochemical Assay, Tobramycin (product code LDO), Class II - Special Controls.

Submitted by Cardiac Resucitator Corp. (Mchenry, US). The FDA issued a Cleared decision on July 19, 1984 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3900 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiac Resucitator Corp. devices

Submission Details

510(k) Number K841556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1984
Decision Date July 19, 1984
Days to Decision 94 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 87d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDO Enzymatic Radiochemical Assay, Tobramycin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3900
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 Toxicology devices follow this clearance model.