Cleared Traditional

K983794 - CHEMO MINI SPIKE PLUS

K983794 is an FDA 510(k) clearance for CHEMO MINI SPIKE PLUS, manufactured by B. Braun of America, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K983794 · B. Braun of America, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
147d
Days
Class 2
Risk

K983794 is an FDA 510(k) clearance for the CHEMO MINI SPIKE PLUS. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by B. Braun of America, Inc. (Allentown, US). The FDA issued a Cleared decision on March 23, 1999 after a review of 147 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all B. Braun of America, Inc. devices

FDA 510(k) Submission Details - K983794

510(k) Number K983794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1998
Decision Date March 23, 1999
Days to Decision 147 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 129d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
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 - LHI Set, I.v. Fluid Transfer

All 73
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K983794.
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