Cleared Traditional

K994375 - HORIZON LIGHT

K994375 is the FDA 510(k) clearance for HORIZON LIGHT by B.Braun Medical, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K994375 · B.Braun Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
72d
Days
Class 2
Risk

K994375 is an FDA 510(k) clearance for the HORIZON LIGHT. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Carrollton, US). The FDA issued a Cleared decision on March 8, 2000 after a review of 72 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 B.Braun Medical, Inc. devices

Submission Details

510(k) Number K994375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1999
Decision Date March 08, 2000
Days to Decision 72 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
57d faster than avg
Panel avg: 129d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 433
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K994039 · Abbott Laboratories · Dec 1999