Cleared Traditional

K953741 - THERMACYL BLOOD/FLUID WARMER

K953741 is an FDA 510(k) clearance for THERMACYL BLOOD/FLUID WARMER, manufactured by Baxter Healthcare Corp. The device is a Class 2 Hematology device with product code BSB cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K953741 · Baxter Healthcare Corp · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
321d
Days
Class 2
Risk

K953741 is an FDA 510(k) clearance for the THERMACYL BLOOD/FLUID WARMER. Classified as Warmer, Blood, Non-electromagnetic Radiation (product code BSB), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on June 26, 1996 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K953741

510(k) Number K953741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1995
Decision Date June 26, 1996
Days to Decision 321 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
208d slower than avg
Panel avg: 113d · This submission: 321d
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 K953741.
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
BLOOD WARMER (CODE 4R4305)
K760012 · Travenol Laboratories, S.A. · Jul 1976