Cleared Traditional

K781156 - DIALYSIS SYS., PDS 400 & RO 400 (FDA 510(k) Clearance)

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

K781156 · Physio-Control Corp. · Toxicology device
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Oct 1978
Decision
105d
Days
Class 2
Risk

K781156 is an FDA 510(k) clearance for the DIALYSIS SYS., PDS 400 & RO 400. Classified as Thin Layer Chromatography, Methamphetamine (product code DJC), Class II - Special Controls.

Submitted by Physio-Control Corp. (Walker, US). The FDA issued a Cleared decision on October 24, 1978 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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 Physio-Control Corp. devices

Submission Details

510(k) Number K781156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1978
Decision Date October 24, 1978
Days to Decision 105 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 87d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJC Thin Layer Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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.