Cleared Traditional

PowerPAK Syringe (K220114) - FDA 510(k) Clearance

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

K220114 · Vault Paragon Group, Inc. · General Hospital
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Jan 2023
Decision
376d
Days
Class 2
Risk

K220114 is an FDA 510(k) clearance for the PowerPAK Syringe. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Vault Paragon Group, Inc. (Oakland, US). The FDA issued a Cleared decision on January 25, 2023 after a review of 376 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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. Elevated predicate reliance profile. 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 Vault Paragon Group, Inc. devices

Submission Details

510(k) Number K220114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2022
Decision Date January 25, 2023
Days to Decision 376 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
247d slower than avg
Panel avg: 129d · This submission: 376d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEG Syringe, Antistick
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - MEG Syringe, Antistick

All 38
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K220114.
Shina Syringe
K231165 · Shina Med Corporation · Oct 2023
Medline Safety Insulin and TB Syringes
K231907 · Medline Industries, LP · Oct 2023
Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110)
K223376 · Cardinal Health200, LLC · Jun 2023
SafeR Syringe and SafeR Sting
K221981 · Roncadelle Operations Srl · Dec 2022
Disposable Automatically Retractable Safety Syringes (with detachable needle)
K222452 · Shantou Wealy Medical Instrument Co.,Ltd · Nov 2022
Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle
K221247 · Jiangsu Kangbao Medical Equipment Co., Ltd. · Nov 2022