Cleared Traditional

K993120 - MODIFIED BLOOD RECIPIENT SET

K993120 is the FDA 510(k) clearance for MODIFIED BLOOD RECIPIENT SET by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code BRZ) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K993120 · Baxter Healthcare Corp · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 1999
Decision
58d
Days
Class 2
Risk

K993120 is an FDA 510(k) clearance for the MODIFIED BLOOD RECIPIENT SET. Classified as Set, Blood Transfusion (product code BRZ), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on November 17, 1999 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K993120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1999
Decision Date November 17, 1999
Days to Decision 58 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 129d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BRZ Set, Blood Transfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 General Hospital devices follow this clearance model.

Regulatory Peers - BRZ Set, Blood Transfusion

Devices cleared under the same product code (BRZ) and FDA review panel - the closest regulatory comparables to K993120.
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