Cleared Traditional

K141200 - PADI-LOCK

K141200 is an FDA 510(k) clearance for PADI-LOCK, manufactured by Padi-Lock, LLC. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K141200 · Padi-Lock, LLC · General Hospital
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Oct 2014
Decision
146d
Days
Class 2
Risk

K141200 is an FDA 510(k) clearance for the PADI-LOCK. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Padi-Lock, LLC (Great Neck, US). The FDA issued a Cleared decision on October 2, 2014 after a review of 146 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.

View all Padi-Lock, LLC devices

FDA 510(k) Submission Details - K141200

510(k) Number K141200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2014
Decision Date October 02, 2014
Days to Decision 146 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 129d · This submission: 146d
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 576
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K141200.
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K142011 · Baxter Healthcare Corporation · Aug 2014
CARESITE LUER ACCESS DEVICE
K140311 · B.Braun Medical, Inc. · May 2014