510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K102900Substantially Equivalent

Heiter 3000 Hyperthermic Perfusion System

Hei, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102900 is the FDA 510(k) clearance record for HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM, a class II device, cleared for Hei, Inc. on under FDA product code LGZ (Warmer, Thermal, Infusion Fluid). FDA records list one 510(k) clearance for Hei, Inc. As of , FDA records show one recall naming K102900.

Clearance record

Decision date
Received
(538 days to decision)
Product code
LGZ Warmer, Thermal, Infusion Fluid
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Hei, Inc. 4801 N. 63rd. St., Boulder CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LGZ

Trailing 12 months
3 clearances under product code LGZ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LGZ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260