Cleared Abbreviated

K053466 - HSINER RESUSCITATOR

K053466 is an FDA 510(k) clearance for HSINER RESUSCITATOR, manufactured by Hsiner Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Abbreviated 510(k) pathway after a 99-day FDA review.

K053466 · Hsiner Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
99d
Days
Class 2
Risk

K053466 is an FDA 510(k) clearance for the HSINER RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Hsiner Co., Ltd. (Temecula, US). The FDA issued a Cleared decision on March 22, 2006 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Hsiner Co., Ltd. devices

FDA 510(k) Submission Details - K053466

510(k) Number K053466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2005
Decision Date March 22, 2006
Days to Decision 99 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 140d · This submission: 99d
Pathway characteristics
Standards-based clearance path.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 102
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K053466.
RESUSCITATION TIMER, MODEL L770-CPR
K073171 · Allied Healthcare Products, Inc. · Jan 2008
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
K070247 · Ohmeda Medical · Apr 2007
RESUSCITATION TIMER, MODEL L770-CPR
K062080 · Allied Healthcare Products, Inc. · Oct 2006
AMBU MARK IV RESUSCITATOR
K053140 · Ambu A/S · Dec 2005
AMBU MARK IV BABY RESUSCITATOR
K053142 · Ambu A/S · Dec 2005
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
K042682 · Ambu, Inc. · Nov 2004