Cleared Traditional

K913386 - CHEMO-PORT

K913386 is an FDA 510(k) clearance for CHEMO-PORT, manufactured by Hdc Corp.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 165-day FDA review.

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

FDA 510(k) Submission Details - K913386

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
Combination Product No
PCCP Authorized No
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.

FMI Device Classification - Class 2, Special Controls

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 271
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K913386.
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INTRAOSSEOUS ACCESS NEEDLE
K915409 · Cook, Inc. · Mar 1992
MX927 BLOOD TRANSFER DEVICE
K913498 · Medex, Inc. · Nov 1991
MEGA MYELOGRAM KIT
K913141 · Megadyne Medical Products, Inc. · Oct 1991
VIAL ACCESS CANNULA
K905664 · Baxter Healthcare Corp · Mar 1991