# K990905: Passy-Muir Low-Profile Tracheostomy Speaking Valve PMV 2020 (Clear) Jit

- Pathway: 510(k) (Traditional)
- Applicant: Passy-Muir, Inc.
- Decided: Jun 11, 1999 after 85 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The PMV 2020 (Clear) JIT is designed to be used in conjunction with the Passy-Muir Adapter PMA-S JIT 4-6 for use on the Pilling Weck metal Jackson Improved tracheostomy tubes sizes #4, #5 and #6 or equivalent in providing vocalization without finger occlusion for both short-term and long-term tracheostomized patients. It is appropriate for neonatal, pediatric and adult patients and is ideal for use in decannulation as an assessment device for physicians, as well as providing the patient comfort and confidence in upper airway usage. The PMV 2020 (Clear) JIT Valve is also designed to be used without an adapter on the Bivona (Non-Foam Filled Cuffed) tracheostomy tubes currently on the market. For Sleep Apnea patients who are tracheostomized as an alternative to plugging when awake Bilateral Vocal Cord Paralysis without significant airway obstruction Tracheomalacia Mild Tracheal and Laryngeal Stenosis Non-Obstructive Laryngeal Tumors (can include patients who have intact vocal cords following surgical resection of the tumor) Neuromuscular Disease Chronic Obstructive Pulmonary Disease Brain Injury Non-Ventilator Dependent Quadriplegics Patients who emotionally or physically are unable to tolerate plugging

Source page: https://510kreport.com/device/K990905
Methodology: https://510kreport.com/methodology