Cleared Traditional

K142096 - T-PIECE RESUSCITATOR

K142096 is an FDA 510(k) clearance for T-PIECE RESUSCITATOR, manufactured by Mercury Medical. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K142096 · Mercury Medical · Anesthesiology device
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Oct 2014
Decision
77d
Days
Class 2
Risk

K142096 is an FDA 510(k) clearance for the T-PIECE RESUSCITATOR. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Mercury Medical (Bonita Springs, US). The FDA issued a Cleared decision on October 17, 2014 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mercury Medical devices

FDA 510(k) Submission Details - K142096

510(k) Number K142096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2014
Decision Date October 17, 2014
Days to Decision 77 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
63d faster than avg
Panel avg: 140d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 - BTL Ventilator, Emergency, Powered (resuscitator)

All 49
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K142096.
Puffin Lite Infant Resuscitation System
K182956 · International Biomedical · Jan 2019
SafeT T-Piece Resuscitator
K173373 · Ventlab, LLC · Nov 2018
VORTRAN GO2VENT
K162968 · Vortran Medical Technology 1, Inc. · Apr 2017
EMERGENCY PORTABLE VENTILATOR
K131098 · Allied Healthcare Products, Inc. · Apr 2014
AHP 300, EMERGENCY PORTABLE VENTILATOR
K132021 · Allied Healthcare Products, Inc. · Apr 2014
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
K090356 · Allied Healthcare Products, Inc. · May 2009