Cleared Traditional

K091336 - IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V

K091336 is an FDA 510(k) clearance for IVNOW MODULAR FLUID WARMER, manufactured by Enthermics Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 366-day FDA review.

K091336 · Enthermics Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
366d
Days
Class 2
Risk

K091336 is an FDA 510(k) clearance for the IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, I.... Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Enthermics Medical Systems, Inc. (Washington, US). The FDA issued a Cleared decision on May 7, 2010 after a review of 366 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K091336

510(k) Number K091336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2009
Decision Date May 07, 2010
Days to Decision 366 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
237d slower than avg
Panel avg: 129d · This submission: 366d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 71
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K091336.
AMSCO WARMING CABINET
K111870 · STERIS Corporation · Jul 2011
AMSCO WARMING CABINET
K110769 · STERIS Corporation · Jun 2011
HYPOTHERMX INTRAVENOUS FLUID WARMER
K103801 · Emit Corporation · May 2011
TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE
K092366 · Thermal Therapeutic Systems, Inc. · Mar 2010
AMSCO WARMING CABINET
K092823 · STERIS Corporation · Dec 2009
BELMONT HYPERTHERMIA PUMP
K090089 · Belmont Instrument Corp. · Feb 2009
K091336 · IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V
Download PDF FDA Summary Enthermics Medical Sy…