Cleared Special

K130867 - ENFLOW IV FLUID WARMER INSULATED STRAP

K130867 is an FDA 510(k) clearance for ENFLOW IV FLUID WARMER INSULATED STRAP, manufactured by Vital Signs, Inc., A GE Healthcare Company. The device is a Class 2 General Hospital device with product code LGZ cleared through the Special 510(k) pathway after a 78-day FDA review.

K130867 · Vital Signs, Inc., A GE Healthcare Company · General Hospital
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Jun 2013
Decision
78d
Days
Class 2
Risk

K130867 is an FDA 510(k) clearance for the ENFLOW IV FLUID WARMER INSULATED STRAP. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Vital Signs, Inc., A GE Healthcare Company (Totowa, US). The FDA issued a Cleared decision on June 14, 2013 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Vital Signs, Inc., A GE Healthcare Company devices

FDA 510(k) Submission Details - K130867

510(k) Number K130867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2013
Decision Date June 14, 2013
Days to Decision 78 days
Submission Type Special
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
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

LGZ Device Classification - Class 2, Special Controls

Product Code LGZ Warmer, Thermal, Infusion Fluid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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.

Regulatory Peers - LGZ Warmer, Thermal, Infusion Fluid

All 65
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K130867.
DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET
K132202 · Enthermics Medical Systems, Inc. · Dec 2013
BELMONT HYPERTHERMIA PUMP
K131519 · Belmont Instrument Corp. · Nov 2013
NATUS WARMETTE BLANKET AND DUAL CABINETS
K132110 · Natus Nicolet Ireland, Ltd. · Oct 2013
ENTERAL NUTRITION WARMER
K122449 · Acacia, Inc. · Jun 2013
ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
K121775 · Vital Signs, Inc., A GE Healthcare Company · Nov 2012
BW685, BW685S
K121198 · Biegler GmbH · Jul 2012