FDA.report

510(k) K220114

Device
PowerPAK Syringe
Applicant
Vault Paragon Group, Inc.
510(k) number
K220114
Product code
MEG
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-25
Date received
2022-01-14
Regulation
880.5860
Classification name
Syringe, Antistick
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Sari Luciano
Address
189 3rd St. A101 Oakland CA US 94607 94607

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code MEG

510(k)DeviceApplicantDecision date
K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.2026-02-18
K250847VaporShieldVault Paragon Group, Inc.2025-12-12
K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.2023-11-21
K231165Shina Syringe; Shina Safety SyringeShina Med Corporation2023-10-27
K231907Medline Safety Insulin and TB SyringesMedline Industries, LP2023-10-18
K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC2023-06-21
K221981SafeR Syringe and SafeR StingRoncadelle Operations Srl2022-12-29
K222452Disposable Automatically Retractable Safety Syringes (with detachable needle)Shantou Wealy Medical Instrument Co.,Ltd2022-11-23
K221247Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable NeedleJiangsu Kangbao Medical Equipment Co., Ltd.2022-11-01
K220057Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose ImmunizationShinva Ande Healthcare Apparatus Co., Ltd.2022-10-07
K221073Sterile Hypodermic Syringes for Single Use with Safety NeedlesSichuan Prius Biotechnology Co., Ltd.2022-10-04
K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd.2022-08-23
K212518Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd.2022-08-18
K213077Automatically Retractable Safety SyringeZhejiang Lingyang Medical Apparatus Co., Ltd.2022-04-27
K210216Disposable Automatically Retractable Insulin Safety SyringeShantou Wealy Medical Instrument Co.,Ltd2022-03-04