Cleared Traditional

K220114 - PowerPAK Syringe

K220114 is an FDA 510(k) clearance for PowerPAK Syringe, manufactured by Vault Paragon Group, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 376-day FDA review.

K220114 · Vault Paragon Group, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K220114

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.

MEG Device Classification - Class 2, Special Controls

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 41
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