Cleared Traditional

CHEMO-PORT (K913386) - FDA 510(k) Clearance

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

K913386 · Hdc Corp. · General Hospital
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Jan 1992
Decision
165d
Days
Class 2
Risk

K913386 is an FDA 510(k) clearance for the CHEMO-PORT. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Hdc Corp. (San Jose, US). The FDA issued a Cleared decision on January 10, 1992 after a review of 165 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Hdc Corp. devices

Submission Details

510(k) Number K913386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received July 29, 1991
Decision Date January 10, 1992
Days to Decision 165 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 129d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 197
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K913386.
LIFESHIELD VIAL ADAPTER
K920737 · Abbott Laboratories · Dec 1992
DISPOSABLE INTROSSEOUS INFUSION NEEDLES
K913258 · Cook, Inc. · Mar 1992
INTRAOSSEOUS ACCESS NEEDLE
K915409 · Cook, Inc. · Mar 1992
VIAL ACCESS CANNULA
K905664 · Baxter Healthcare Corp · Mar 1991
B-D PEND NEEDLE
K895630 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
NON-CORING NEEDLES
K883009 · Quinton, Inc. · Oct 1988