Cleared Abbreviated

K991159 - PRISMATHERM II, ASTOLINE

K991159 is an FDA 510(k) clearance for PRISMATHERM II, manufactured by Stihler Electronic GmbH. The device is a Class 2 Hematology device with product code BSB cleared through the Abbreviated 510(k) pathway after a 149-day FDA review.

K991159 · Stihler Electronic GmbH · Hematology device
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Sep 1999
Decision
149d
Days
Class 2
Risk

K991159 is an FDA 510(k) clearance for the PRISMATHERM II, ASTOLINE. Classified as Warmer, Blood, Non-electromagnetic Radiation (product code BSB), Class II - Special Controls.

Submitted by Stihler Electronic GmbH (Sound Beach, US). The FDA issued a Cleared decision on September 3, 1999 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9205 - the FDA hematology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Stihler Electronic GmbH devices

FDA 510(k) Submission Details - K991159

510(k) Number K991159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1999
Decision Date September 03, 1999
Days to Decision 149 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 113d · This submission: 149d
Pathway characteristics
Standards-based clearance path.

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 K991159.
BELMONT BUDDY PLUS FLUID WARMER
K062774 · Belmont Instrument Corp. · Oct 2006
BELMONT BUDDY FLUID WARMER
K052547 · Belmont Instrument Corp. · Oct 2005
MICROHEATER
K031478 · Belmont Instrument Corp. · Jul 2003
ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
K991160 · Stihler Electronic GmbH · Sep 1999
THERMAL ANGEL
K984640 · Estill Medical Technologies, Inc. · Jul 1999
BAIR HUGGER BLOOD/FLUID WARMER
K973741 · Augustine Medical, Inc. · Apr 1998