Cleared Traditional

K093913 - MERCURY MEDICAL T-PIECE RESUSCITATOR

K093913 is an FDA 510(k) clearance for MERCURY MEDICAL T-PIECE RESUSCITATOR, manufactured by Mercury Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K093913 · Mercury Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
105d
Days
Class 2
Risk

K093913 is an FDA 510(k) clearance for the MERCURY MEDICAL T-PIECE RESUSCITATOR. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Mercury Medical, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on April 6, 2010 after a review of 105 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K093913

510(k) Number K093913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2009
Decision Date April 06, 2010
Days to Decision 105 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
35d faster than avg
Panel avg: 140d · This submission: 105d
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 80
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K093913.
MANUJET III
K112783 · VBM Medizintechnik GmbH · Dec 2011
RESUSCI FLOW
K102542 · Atom Medical Corporation · Apr 2011
CAREVENT HANDHELD CPAP SYSTEM
K093862 · O-Two Medical Technologies, Inc. · May 2010
MOVES
K093261 · Thornhill Research, Inc. · Mar 2010
ISPIRA RESUSCITATION UNIT
K092085 · Neoforce Group, Inc. · Oct 2009
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
K090356 · Allied Healthcare Products, Inc. · May 2009