Cleared Traditional

K223788 - The MedSource TrueSafe Blood Control I....

K223788 is an FDA 510(k) clearance for The MedSource TrueSafe Blood Control I...., manufactured by Medsource International, LLC. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K223788 · Medsource International, LLC · General Hospital
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Sep 2023
Decision
270d
Days
Class 2
Risk

K223788 is an FDA 510(k) clearance for the The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource .... Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Medsource International, LLC (Chanhassen, US). The FDA issued a Cleared decision on September 15, 2023 after a review of 270 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Medsource International, LLC devices

FDA 510(k) Submission Details - K223788

510(k) Number K223788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2022
Decision Date September 15, 2023
Days to Decision 270 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
141d slower than avg
Panel avg: 129d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 299
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K223788.
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