Cleared Special

K012031 - MODIFICATION TO THERMAL ANGEL

K012031 is an FDA 510(k) clearance for MODIFICATION TO THERMAL ANGEL, manufactured by Estill Medical Technologies, Inc.. The device is a Class 2 Hematology device with product code BSB cleared through the Special 510(k) pathway after a 28-day FDA review.

K012031 · Estill Medical Technologies, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
28d
Days
Class 2
Risk

K012031 is an FDA 510(k) clearance for the MODIFICATION TO 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 26, 2001 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9205 - the FDA hematology 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.

FDA 510(k) Submission Details - K012031

510(k) Number K012031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2001
Decision Date July 26, 2001
Days to Decision 28 days
Submission Type Special
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
85d faster than avg
Panel avg: 113d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 13
Devices cleared under the same product code (BSB) and FDA review panel - the closest regulatory comparables to K012031.
BELMONT BUDDY FLUID WARMER
K052547 · Belmont Instrument Corp. · Oct 2005
MICROHEATER
K031478 · Belmont Instrument Corp. · Jul 2003
ASTOFLO
K020060 · Nats Corp. · Mar 2002
PRISMATHERM II, ASTOLINE
K991159 · Stihler Electronic GmbH · Sep 1999
ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
K991160 · Stihler Electronic GmbH · Sep 1999
THERMAL ANGEL
K984640 · Estill Medical Technologies, Inc. · Jul 1999
K012031 · MODIFICATION TO THERMAL ANGEL
Download PDF FDA Summary Estill Medical Techno…