Cleared Traditional

K102900 - HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM

K102900 is an FDA 510(k) clearance for HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM, manufactured by Hei, Inc.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 538-day FDA review.

K102900 · Hei, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
538d
Days
Class 2
Risk

K102900 is an FDA 510(k) clearance for the HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Hei, Inc. (Boulder, US). The FDA issued a Cleared decision on March 21, 2012 after a review of 538 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

FDA 510(k) Submission Details - K102900

510(k) Number K102900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2010
Decision Date March 21, 2012
Days to Decision 538 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
409d slower than avg
Panel avg: 129d · This submission: 538d
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 73
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K102900.
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AMSCO WARMING CABINET
K111870 · STERIS Corporation · Jul 2011
AMSCO WARMING CABINET
K110769 · STERIS Corporation · Jun 2011
K102900 · HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM
Download PDF FDA Summary Hei, Inc.