Cleared Traditional

K902444 - CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP (FDA 510(k) Clearance)

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

K902444 · Intramed Laboratories, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
90d
Days
Class 2
Risk

K902444 is an FDA 510(k) clearance for the CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP. Classified as Withdrawal/infusion Pump (product code DQI), Class II - Special Controls.

Submitted by Intramed Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on August 30, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1800 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Intramed Laboratories, Inc. devices

Submission Details

510(k) Number K902444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1990
Decision Date August 30, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 128d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQI Withdrawal/infusion Pump
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1800
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 General Hospital devices follow this clearance model.