# K122111: Respironics Simplyclear Device

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Dec 31, 2012 after 167 days
- Product code: SDT (Intra-Pulmonary Percussive Vibration (Ipv) Devices)
- Device class: 2
- Regulation: 21 CFR 868.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K884098 (1988). 8 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024309: The Vest Airway Clearance System, Model 104, Advanced Respiratory (2003) Summary page 6.
- K002598: Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual Timing, J. H. Emerson Co. (2000) Summary page 6.
- K072292: Negavent Plus Pegaso Cough, Model: DA-3 Plus, Dima Italia Srl (2008) Summary page 6.
- K121955: Coughassist T70 Device, Respironics, Inc. (2012). Cleared while this submission was under review Summary page 6.

## Most influential descendants
- K140598: Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough Perc (2014), 1 descendant of its own
- K253001: KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) (2026), 0 descendants of its own
- K241091: SIMEOX 200 Airway Clearance Device (2024), 0 descendants of its own
- K140605: Minipegaso Cough, Minipegaso a-Cough, Minipegaso a-Coug Perc (2014), 0 descendants of its own

## Indications for use
The Philips Respironics SimplyClear device promotes airway clearance by gradually applying air pulse generated high frequency oscillatory vibrations on the positive and negative pressures applied to the chest wall via the airways. The high frequency oscillatory vibrations release mucus from the bronchial walls, increasing mobilization. The shift in pressure produces a high expiratory flow from the lungs, promoting the clearance of the mobilized secretions via coughing. The Philips Respironics SimplyClear device may be used either with a facemask or mouthpiece, or with an adapter to a paticnt’s endotracheal or tracheostomy tube. It is for use on adult or pediatric patients having difficulty with secretion clearance and/or inability to cough. The SimplyClear device is for use in a hospital, institutional environment or in the home.

Source page: https://510kreport.com/device/K122111
Methodology: https://510kreport.com/methodology