Cleared Traditional

K932538 - CABOT MEDICAL IRRIGATION FLUID WARMER SETS (FDA 510(k) Clearance)

Class I General Hospital device.

K932538 · Cabot Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
272d
Days
Class 1
Risk

K932538 is an FDA 510(k) clearance for the CABOT MEDICAL IRRIGATION FLUID WARMER SETS. Classified as Warmer, Irrigation Solution (product code LHC), Class I - General Controls.

Submitted by Cabot Medical Corp. (Langhorne, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 272 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 890.5950 - 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 Cabot Medical Corp. devices

Submission Details

510(k) Number K932538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1993
Decision Date February 22, 1994
Days to Decision 272 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 128d · This submission: 272d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LHC Warmer, Irrigation Solution
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5950
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.