Cleared Traditional

PiccGuard (K191195) - FDA 510(k) Clearance

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

K191195 · Piccguard, LLC · General Hospital
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Jan 2020
Decision
245d
Days
Class 2
Risk

K191195 is an FDA 510(k) clearance for the PiccGuard. Classified as Catheter Access Cover, Tamper-resistant (product code PZW), Class II - Special Controls.

Submitted by Piccguard, LLC (Beloit, US). The FDA issued a Cleared decision on January 3, 2020 after a review of 245 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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 Piccguard, LLC devices

Submission Details

510(k) Number K191195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2019
Decision Date January 03, 2020
Days to Decision 245 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
116d slower than avg
Panel avg: 129d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PZW Catheter Access Cover, Tamper-resistant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
Definition A Tamper Resistant Catheter Access Cover Is Intended To Control Unauthorized Access To A Central Venous Catheter
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 Consultant

Smith Associates
E.J. Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.