Cleared Traditional

K190630 - SolidAIRity III Airway Stabilization Sy...

K190630 is the FDA 510(k) clearance for SolidAIRity III Airway Stabilization Sy... by Securisyn Medical, LLC. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K190630 · Securisyn Medical, LLC · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
211d
Days
Class 2
Risk

K190630 is an FDA 510(k) clearance for the SolidAIRity III Airway Stabilization System. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Securisyn Medical, LLC (Highlands Ranch, US). The FDA issued a Cleared decision on October 9, 2019 after a review of 211 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - the FDA anesthesiology and respiratory 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Securisyn Medical, LLC devices

Submission Details

510(k) Number K190630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2019
Decision Date October 09, 2019
Days to Decision 211 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 140d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BTR Tube, Tracheal (w/wo Connector)

All 107
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K190630.
Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff
K190878 · Salter Labs, Inc. · Jan 2020
Endotracheal Tube with Evacuation Lumen
K182739 · Well Lead Medical Co., Ltd. · Dec 2019
Sheridan Spiral-Flex Endotracheal Tubes
K192324 · Teleflexmedical, Inc. · Dec 2019
Yikang Endotracheal Tube
K190213 · Jiangxi Yikang Medical Instrument Group Co., Ltd. · Sep 2019
Endotracheal Tube
K190274 · Tianjin Medis Medical Device Co., Ltd. · Jul 2019
VivaSight-SL (TVT) system
K181880 · Etview , Ltd. · Nov 2018