Cleared Traditional

K932538 - CABOT MEDICAL IRRIGATION FLUID WARMER SETS

K932538 is an FDA 510(k) clearance for CABOT MEDICAL IRRIGATION FLUID WARMER SETS, manufactured by Cabot Medical Corp.. The device is a Class 1 General Hospital device with product code LHC cleared through the Traditional 510(k) pathway after a 272-day FDA review.

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

FDA 510(k) Submission Details - K932538

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 129d · This submission: 272d
Pathway characteristics
Predicate-based equivalence.

LHC Device Classification - Class 1, General Controls

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.