Cleared Traditional

K112915 - SPIRTIUS CUFF INFLATION SYRINGE

K112915 is an FDA 510(k) clearance for SPIRTIUS CUFF INFLATION SYRINGE, manufactured by Spiritus Technologies, LLC. The device is a Class 2 Anesthesiology device with product code BSK cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K112915 · Spiritus Technologies, LLC · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
235d
Days
Class 2
Risk

K112915 is an FDA 510(k) clearance for the SPIRTIUS CUFF INFLATION SYRINGE. Classified as Cuff, Tracheal Tube, Inflatable (product code BSK), Class II - Special Controls.

Submitted by Spiritus Technologies, LLC (Lenexa, US). The FDA issued a Cleared decision on May 25, 2012 after a review of 235 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5750 - 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 Spiritus Technologies, LLC devices

FDA 510(k) Submission Details - K112915

510(k) Number K112915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2011
Decision Date May 25, 2012
Days to Decision 235 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 140d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSK Device Classification - Class 2, Special Controls

Product Code BSK Cuff, Tracheal Tube, Inflatable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5750
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 - BSK Cuff, Tracheal Tube, Inflatable

All 20
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K112915.
VORTRAN Cuff Inflator (VCI)
K173914 · Vortran Medical Technology 1, Inc. · May 2018
IntelliCuff
K150893 · Hamilton Medical AG · Jan 2016
CUFF PILOT, SURE SEAL
K142103 · Teleflexmedical, Inc. · May 2015
PILOT TUBE REPAIR KIT
K113644 · Instrumentation Industries, Inc. · Jan 2012
CUFF SENTRY
K102674 · Ventlab Corp. · Jul 2011
PILOT TUBE REPAIR KIT
K973755 · Instrumentation Industries, Inc. · Dec 1997