Cleared Traditional

K901531 - PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE

K901531 is an FDA 510(k) clearance for PTI INTRA-ARTR REUSABLE CORONARY ARTERY..., manufactured by Pioneering Technologies, Inc.. The device is a Class 2 Toxicology device with product code DNP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K901531 · Pioneering Technologies, Inc. · Toxicology device
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Jun 1990
Decision
90d
Days
Class 2
Risk

K901531 is an FDA 510(k) clearance for the PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE. Classified as Thin Layer Chromatography, Ethosuximide (product code DNP), Class II - Special Controls.

Submitted by Pioneering Technologies, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on June 20, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3380 - 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 Pioneering Technologies, Inc. devices

FDA 510(k) Submission Details - K901531

510(k) Number K901531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1990
Decision Date June 20, 1990
Days to Decision 90 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
3d slower than avg
Panel avg: 87d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DNP Device Classification - Class 2, Special Controls

Product Code DNP Thin Layer Chromatography, Ethosuximide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3380
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.