Cleared Traditional

K984640 - THERMAL ANGEL

K984640 is an FDA 510(k) clearance for THERMAL ANGEL, manufactured by Estill Medical Technologies, Inc.. The device is a Class 2 Hematology device with product code BSB cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K984640 · Estill Medical Technologies, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
182d
Days
Class 2
Risk

K984640 is an FDA 510(k) clearance for the THERMAL ANGEL. Classified as Warmer, Blood, Non-electromagnetic Radiation (product code BSB), Class II - Special Controls.

Submitted by Estill Medical Technologies, Inc. (Dallas, US). The FDA issued a Cleared decision on July 1, 1999 after a review of 182 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9205 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Estill Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K984640

510(k) Number K984640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1998
Decision Date July 01, 1999
Days to Decision 182 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 113d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSB Device Classification - Class 2, Special Controls

Product Code BSB Warmer, Blood, Non-electromagnetic Radiation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9205
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 Hematology devices follow this clearance model.

Regulatory Peers - BSB Warmer, Blood, Non-electromagnetic Radiation

All 10
Devices cleared under the same product code (BSB) and FDA review panel - the closest regulatory comparables to K984640.
MICROHEATER
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PRISMATHERM II, ASTOLINE
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ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
K991160 · Stihler Electronic GmbH · Sep 1999
BAIR HUGGER BLOOD/FLUID WARMER
K973741 · Augustine Medical, Inc. · Apr 1998
THERMACYL BLOOD/FLUID WARMER
K953741 · Baxter Healthcare Corp · Jun 1996
BLOOD WARMER (CODE 4R4305)
K760012 · Travenol Laboratories, S.A. · Jul 1976