Cleared Traditional

K080609 - SWC/DWC WARMING CABINETS

K080609 is an FDA 510(k) clearance for SWC/DWC WARMING CABINETS, manufactured by Mac Medical. The device is a Class 1 General Hospital device with product code LHC cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K080609 · Mac Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
102d
Days
Class 1
Risk

K080609 is an FDA 510(k) clearance for the SWC/DWC WARMING CABINETS. Classified as Warmer, Irrigation Solution (product code LHC), Class I - General Controls.

Submitted by Mac Medical (Deer Field, US). The FDA issued a Cleared decision on June 13, 2008 after a review of 102 days - within the typical 510(k) review window.

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 Mac Medical devices

FDA 510(k) Submission Details - K080609

510(k) Number K080609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2008
Decision Date June 13, 2008
Days to Decision 102 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
27d faster than avg
Panel avg: 129d · This submission: 102d
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.

Regulatory Peers - LHC Warmer, Irrigation Solution

All 7
Devices cleared under the same product code (LHC) and FDA review panel - the closest regulatory comparables to K080609.
UROSURGE UROTHERM FLUID WARMING SYSTEM
K965136 · Princeton Regulatory Assoc. · Oct 1998
WARMETTE
K971117 · Olympic Medical Corp. · Aug 1997
NEZHAT-DORSEY THERMAL RETENTION SYSTEM
K951300 · American Hydro-Surgical Instruments, Inc. · Jun 1995
CABOT MEDICAL IRRIGATION FLUID WARMER SETS
K932538 · Cabot Medical Corp. · Feb 1994
MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM
K933726 · Augustine Medical, Inc. · Jan 1994
ORS-2000 SERIES
K921633 · Mnlase, Inc. · Jun 1992