Cleared Traditional

K790445 - ULTRA-FREE

K790445 is an FDA 510(k) clearance for ULTRA-FREE, manufactured by Millipore Corp.. The device is a Class 1 Toxicology device with product code JRL cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K790445 · Millipore Corp. · Toxicology device
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Jun 1979
Decision
115d
Days
Class 1
Risk

K790445 is an FDA 510(k) clearance for the ULTRA-FREE. Classified as Unit, Filter, Membrane (product code JRL), Class I - General Controls.

Submitted by Millipore Corp. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1979 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2050 - 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 Millipore Corp. devices

FDA 510(k) Submission Details - K790445

510(k) Number K790445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1979
Decision Date June 28, 1979
Days to Decision 115 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
28d slower than avg
Panel avg: 87d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

JRL Device Classification - Class 1, General Controls

Product Code JRL Unit, Filter, Membrane
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.