Cleared Traditional

K770232 - BLOOD/FLUID WARMER MODEL DW-1000A (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K770232 · Gorman Rupp Industries · Hematology device
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Feb 1977
Decision
7d
Days
Class 2
Risk

K770232 is an FDA 510(k) clearance for the BLOOD/FLUID WARMER MODEL DW-1000A. Classified as Warmer, Blood, Non-electromagnetic Radiation (product code BSB), Class II - Special Controls.

Submitted by Gorman Rupp Industries (Mchenry, US). The FDA issued a Cleared decision on February 14, 1977 after a review of 7 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gorman Rupp Industries devices

Submission Details

510(k) Number K770232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1977
Decision Date February 14, 1977
Days to Decision 7 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 113d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.