Cleared Traditional

K880442 - BRUSHRITE

K880442 is an FDA 510(k) clearance for BRUSHRITE, manufactured by Pro Care Laboratories, Inc.. The device is a Class 2 Anesthesiology device with product code JEG cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K880442 · Pro Care Laboratories, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
104d
Days
Class 2
Risk

K880442 is an FDA 510(k) clearance for the BRUSHRITE. Classified as Analyzer, Gas, Argon, Gaseous-phase (product code JEG), Class II - Special Controls.

Submitted by Pro Care Laboratories, Inc. (West Point, US). The FDA issued a Cleared decision on May 16, 1988 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1075 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K880442

510(k) Number K880442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1988
Decision Date May 16, 1988
Days to Decision 104 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 140d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEG Device Classification - Class 2, Special Controls

Product Code JEG Analyzer, Gas, Argon, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1075
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 Anesthesiology devices follow this clearance model.

K880442 · BRUSHRITE
Download PDF Pro Care Laboratories…