# K200988: Maximus System

- Pathway: 510(k) (Special)
- Applicant: Hill-Rom Services Pte, Ltd.
- Decided: May 26, 2020 after 41 days
- Product code: NHJ (Device, Positive Pressure Breathing, Intermittent)
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 10 (9 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K944900 (1995). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192143: Maximus System, Hill-Rom Services Pte, Ltd. (2020) Summary page 4.

## Most influential descendants
- K231728: BiWaze Clear System (2024), 1 descendant of its own
- K260604: BiWaze Clear System (2026), 0 descendants of its own
- K213564: BiWaze Clear System (2022), 0 descendants of its own

## Recalls of this device
- Aug 3, 2026 · Class II · Z-3257-2026: Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specificatio
- May 21, 2026 · Class I · Z-2549-2026: There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffecti
- May 21, 2026 · Class I · Z-2551-2026: There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffecti
- May 21, 2026 · Class I · Z-2548-2026: There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffecti
- May 21, 2026 · Class I · Z-2550-2026: There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffecti
- Feb 18, 2026 · Class I · Z-1637-2026: Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desatu
- May 30, 2024 · Class I · Z-2321-2024: Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
- May 30, 2024 · Class I · Z-2322-2024: Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
- Apr 26, 2022 · Class I · Z-1139-2022: There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
- Apr 26, 2022 · Class I · Z-1138-2022: There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.

## Indications for use
The Maximus™ System provides features of both the Synclara™ System and the Volara™ System. The Maximus™ System, when used as a Synclara™ Cough System is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness. The Maximus™ System, when used as a Volara™ System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with oxygen supply. Patient Population The Maximus™ System, when used as a Synclara™ Cough System, is intended to deliver therapy to the population of pediatric to adult patients in both acute and home care settings. The Maximus™ System, when used as a Volara™ System, is intended to deliver therapy to adults and children over the age of 2 in the acute care setting. The Maximus™ System, when used as a Volara™ System, is intended to deliver therapy to adults and children over the age of 5 in the home care setting.

Source page: https://510kreport.com/device/K200988
Methodology: https://510kreport.com/methodology