WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K250847

510(k) cleared

VaporShield

Vault Paragon Group, Inc. · Dec 12, 2025 · K250847

FDA cleared the VaporShield from Vault Paragon Group, Inc. on Dec 12, 2025 under K250847, a traditional 510(k). The device falls under product code MEG, Syringe, Antistick, regulated at 21 CFR 880.5860 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Mar 20, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Vault Paragon Group, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250847?

K250847 is the FDA 510(k) for VaporShield, submitted by Vault Paragon Group, Inc.. FDA's decision date was Dec 12, 2025, under product code MEG (Syringe, Antistick).

Who makes the VaporShield?

Vault Paragon Group, Inc., based in Garden City, ID, is the applicant of record for K250847.

How long did the K250847 review take?

FDA received the submission on Mar 20, 2025 and issued its decision on Dec 12, 2025, 267 days later.

← All decisions in December 2025