Cleared Traditional

HYDRO-SIL(TM) COATED GUIDEWIRES (K900822) - FDA 510(k) Clearance

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

K900822 · National-Standard Medical Products · Toxicology device
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Jul 1990
Decision
146d
Days
Class 2
Risk

K900822 is an FDA 510(k) clearance for the HYDRO-SIL(TM) COATED GUIDEWIRES. Classified as Fluorometer, Lead (dedicated Instruments) (product code DOX), Class II - Special Controls.

Submitted by National-Standard Medical Products (Gainesville, US). The FDA issued a Cleared decision on July 17, 1990 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3550 - 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 National-Standard Medical Products devices

Submission Details

510(k) Number K900822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1990
Decision Date July 17, 1990
Days to Decision 146 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 87d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DOX Fluorometer, Lead (dedicated Instruments)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3550
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.