Cleared Traditional

K160950 - MINISCAV

K160950 is an FDA 510(k) clearance for MINISCAV, manufactured by Sedation Systems, LLC. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 395-day FDA review.

K160950 · Sedation Systems, LLC · Anesthesiology device
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May 2017
Decision
395d
Days
Class 2
Risk

K160950 is an FDA 510(k) clearance for the MINISCAV. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Sedation Systems, LLC (Clearwater, US). The FDA issued a Cleared decision on May 5, 2017 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5430 - 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. Elevated predicate reliance profile. 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 Sedation Systems, LLC devices

FDA 510(k) Submission Details - K160950

510(k) Number K160950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2016
Decision Date May 05, 2017
Days to Decision 395 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
255d slower than avg
Panel avg: 140d · This submission: 395d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBN Device Classification - Class 2, Special Controls

Product Code CBN Apparatus, Gas-scavenging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5430
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 - CBN Apparatus, Gas-scavenging

All 14
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K160950.
Nitronox Scavenger Plus
K223452 · Parker Hannifin Corporation · Mar 2023
Dynamic Gas Scavenging System 2 (DGSS - 2)
K193646 · Anesthetic Gas Reclamation, Inc. · Dec 2020
ISO-GARD MASK
K142138 · Teleflexmedical, Inc. · Oct 2014
ISO-GARD MASK
K132729 · Teleflexmedical, Inc. · Jan 2014
ISO-GARD CLEARAIR MASK
K123176 · Teleflexmedical, Inc. · Feb 2013
RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963
K893532 · Medipart Jerry Alexander · Aug 1989