Cleared Traditional

K841556 - HEART - AID ALS, 95

K841556 is an FDA 510(k) clearance for HEART - AID ALS, manufactured by Cardiac Resucitator Corp.. The device is a Class 2 Toxicology device with product code LDO cleared through the Traditional 510(k) pathway after a 94-day FDA review.

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

FDA 510(k) Submission Details - K841556

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
Combination Product No
PCCP Authorized No
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.

LDO Device Classification - Class 2, Special Controls

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.