MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE

• K Number: K012485
• Device Name: MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE
• Manufacturer: KING SYSTEMS CORP.
• Date Cleared: 2001-10-09 ( 68 days)
• Product Code: CAH
• Regulation Number: 868.5260
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

• A breathing circuit bacterial filter is a device that is intended to remove 1. microbiological and particulate matter from the gases of a breathing circuit.
• A heat and moisture exchanger (HME) is a device intended to be 2. positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by a patient during anesthesia or ventilator care.
• ventifator care.
  Each All-Round® filter or HME/filter is intended for adult patients 3. whose respiratory status will not be compromised by the dead space.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria or a study proving that the device meets it. The document is an FDA 510(k) clearance letter for a breathing circuit bacterial filter, which indicates that the device has been found substantially equivalent to predicate devices. It does not include specific performance data or a study description as requested.

Regulation Number and Section

§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).