510(k) K250847

Device: VaporShield
Applicant: Vault Paragon Group, Inc.
510(k) number: K250847
Product code: MEG
Decision: Substantially Equivalent (SESE)
Decision date: 2025-12-12
Date received: 2025-03-20
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

Related Records

Applicant Contact

Contact: Sari Luciano
Address: 199 E 52nd St. Suite 240 Garden City ID US 83714 83714

FDA Registration Numbers

3012050423
1423537
3036679495
3016685880
3012777736
3008789114
3017770710
3014456066
3011088743
3014747754
3007392007
3007279404
1920898
3033536319
3010085632
3010934635
3002807968
3009746425
3003829571
3023228837
2183771
3013513377
8040619
3002907620
3014662855
1319639
3012116434
3007441619
3018681450
1915484
3004458481
1423507
3029755538
3027338968
3004417597
3009742443
3014162214
9610847
3007594734
3017717188
1220477
3003681915
1921846
3010515547
3014570560
3024508819
3008307705
3034667025
3012646696
3023339256
3038220293
3012039263
3010864832
1450743
3022699058
3007490412
3015142721
2243072
3020294761
3015972753
1649518
1647137
3010405396
1213809
3030626857
3004143450
3005246939
3006973666
3043226252
3036722184
3013187142
3038356900
3017509841
3004416208
3007590959
3004425647
3037918935
3004496829
3016904853

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MEG

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K252098	PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)	Methyl Co., Ltd.	2026-02-18
K230287	SaviSafe Safety Device	Suzhou Savicred Biotechnology Co., Ltd.	2023-11-21
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K231907	Medline Safety Insulin and TB Syringes	Medline Industries, LP	2023-10-18
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K220114	PowerPAK Syringe	Vault Paragon Group, Inc.	2023-01-25
K221981	SafeR Syringe and SafeR Sting	Roncadelle Operations Srl	2022-12-29
K222452	Disposable Automatically Retractable Safety Syringes (with detachable needle)	Shantou Wealy Medical Instrument Co.,Ltd	2022-11-23
K221247	Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle	Jiangsu Kangbao Medical Equipment Co., Ltd.	2022-11-01
K220057	Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization	Shinva Ande Healthcare Apparatus Co., Ltd.	2022-10-07
K221073	Sterile Hypodermic Syringes for Single Use with Safety Needles	Sichuan Prius Biotechnology Co., Ltd.	2022-10-04
K220061	Safety Insulin Syringes	Berpu Medical Technology Co., Ltd.	2022-08-23
K212518	Jeesung Safety Syringe and Single Use Needles	Jeesung Medical Co., Ltd.	2022-08-18
K213077	Automatically Retractable Safety Syringe	Zhejiang Lingyang Medical Apparatus Co., Ltd.	2022-04-27
K210216	Disposable Automatically Retractable Insulin Safety Syringe	Shantou Wealy Medical Instrument Co.,Ltd	2022-03-04