Cleared Traditional

K010279 - MEDISYSTEMS LUER ACCESS INJECTION SITE

K010279 is an FDA 510(k) clearance for MEDISYSTEMS LUER ACCESS INJECTION SITE, manufactured by Medisystems Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K010279 · Medisystems Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
119d
Days
Class 2
Risk

K010279 is an FDA 510(k) clearance for the MEDISYSTEMS LUER ACCESS INJECTION SITE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Medisystems Corp. (Seattle, US). The FDA issued a Cleared decision on May 29, 2001 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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.

FDA 510(k) Submission Details - K010279

510(k) Number K010279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2001
Decision Date May 29, 2001
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 1177
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K010279.
PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK
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EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
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GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES
K011120 · Nipro Diabetes Systems, Inc. · May 2001
SIMPLICITY WING INFUSION SET
K010886 · Sterling Medivations, Inc. · Apr 2001
K010279 · MEDISYSTEMS LUER ACCESS INJECTION SITE
Download PDF FDA Summary Medisystems Corp.