Cleared Traditional

K973741 - BAIR HUGGER BLOOD/FLUID WARMER

K973741 is an FDA 510(k) clearance for BAIR HUGGER BLOOD/FLUID WARMER, manufactured by Augustine Medical, Inc.. The device is a Class 2 Hematology device with product code BSB cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K973741 · Augustine Medical, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
211d
Days
Class 2
Risk

K973741 is an FDA 510(k) clearance for the BAIR HUGGER BLOOD/FLUID WARMER. Classified as Warmer, Blood, Non-electromagnetic Radiation (product code BSB), Class II - Special Controls.

Submitted by Augustine Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on April 30, 1998 after a review of 211 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 Augustine Medical, Inc. devices

FDA 510(k) Submission Details - K973741

510(k) Number K973741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1997
Decision Date April 30, 1998
Days to Decision 211 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
98d slower than avg
Panel avg: 113d · This submission: 211d
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.