Cleared Traditional

K840846 - STERILE HICHMAN/BROVIAC INJECTION CAP

K840846 is the FDA 510(k) clearance for STERILE HICHMAN/BROVIAC INJECTION CAP by Evermed, Inc.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K840846 · Evermed, Inc. · General Hospital
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Jul 1984
Decision
133d
Days
Class 2
Risk

K840846 is an FDA 510(k) clearance for the STERILE HICHMAN/BROVIAC INJECTION CAP. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Evermed, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1984 after a review of 133 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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 Evermed, Inc. devices

Submission Details

510(k) Number K840846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date July 06, 1984
Days to Decision 133 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 129d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 190
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K840846.
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K834383 · Burron Medical Products, Inc. · May 1984
MULTI-LUMEN CENTRAL VENOUS CATH. KIT
K834473 · Burron Medical Products, Inc. · Apr 1984