Cleared Traditional

SERAGARD VASCULAR ACCESS PATCH (K001175) - FDA 510(k) Clearance

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

K001175 · Platinum Services, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
160d
Days
Class 2
Risk

K001175 is an FDA 510(k) clearance for the SERAGARD VASCULAR ACCESS PATCH. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Platinum Services, Inc. (Dequincy, US). The FDA issued a Cleared decision on September 18, 2000 after a review of 160 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 Platinum Services, Inc. devices

Submission Details

510(k) Number K001175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2000
Decision Date September 18, 2000
Days to Decision 160 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
31d slower than avg
Panel avg: 129d · This submission: 160d
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 183
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K001175.
BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET
K011984 · Becton, Dickinson & CO · Aug 2001
BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
K003461 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 2001
B-D ULTRA-FINE III PEN NEEDLE
K002938 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 2000
LUER ACCESS UNIVERSAL VIAL ADAPTER
K000657 · Baxter Healthcare Corp · Mar 2000
BECTON DICKINSON BLUNT PLASTIC CANNULA
K974363 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998
BECTON DICKINSON TWINPAK
K974006 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1998