Cleared Traditional

K952201 - PORT-A-CATH ACCESS KIT

K952201 is the FDA 510(k) clearance for PORT-A-CATH ACCESS KIT by Medi-Flex Hospital Products, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K952201 · Medi-Flex Hospital Products, Inc. · General Hospital
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Oct 1995
Decision
147d
Days
Class 2
Risk

K952201 is an FDA 510(k) clearance for the PORT-A-CATH ACCESS KIT. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Medi-Flex Hospital Products, Inc. (Overland Park, US). The FDA issued a Cleared decision on October 4, 1995 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 880.5860 - 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 Medi-Flex Hospital Products, Inc. devices

Submission Details

510(k) Number K952201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1995
Decision Date October 04, 1995
Days to Decision 147 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
18d slower than avg
Panel avg: 129d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 250
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K952201.
GENOTROPIN MIXER
K954337 · Pharmacia, Inc. · Nov 1995
B-D PEN ULTRA
K951919 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1995
PISTON SYRINGE
K951025 · Pharmacia, Inc. · Oct 1995
PTFE SYRINGE FILTER
K952918 · B.Braun Medical, Inc. · Sep 1995
STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS
K950824 · Stryker Corp. · Aug 1995
MONOJECT(R) PISTON SYRINGES
K945715 · Sherwood Medical Co. · Mar 1995