510(k) · Cleared
Recalled · Class I · 2026Maximus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom Services Pte, Ltd. · NHJ Device, Positive Pressure Breathing, Intermittent
Cleared on Feb 14, 2020 as substantially equivalent to K124032 (Hill-Rom Services Pte, Ltd., 2013) and 3 other predicates after a 190-day review. Its family tree reaches back 5 generations to 1995. 2 of the 16 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 7 times, including 7 Class I recalls.
- Decided
- Feb 14, 2020
- Review
- 190 days
- Class
- Class II
- Product code
- NHJ
- Recalls
- 7 (7 Class I)
- Predicates
- 4
Its longest line of descent runs back 5 generations to K944900 (1995). 11 ancestors in all, the oldest K895485 (1989). 4 later devices descend from it, 1 citing it directly. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK944900 TherapepDhd Diemolding Healthcare Div. · 1995
- 4 generations backK991300 Boeing, Positive Airway Pressure (Pap) Therapy DeviceDhd Healthcare Corp. · 1999
- 3 generations backK051964 PowernebComedica, Inc. · 2005
- 2 generations backK124032 MetanebHill-Rom Services Pte, Ltd. · 2013
- 1 generation backK151689 MetaNeb 4 SystemHill-Rom Services Pte, Ltd. · 2016
- This deviceK192143 Maximus SystemHill-Rom Services Pte, Ltd. · 2020
- Descendant · cites it directly · 3 of its ownK200988 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK231728 BiWaze Clear SystemAbmrc, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK260604 BiWaze Clear SystemAbmrc, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK213564 BiWaze Clear SystemAbmrc, LLC · 2022
Class I recalls in this family
- K200988 Maximus Systemcites it directly · 2020
Most influential descendants
Showing 4 of 4 · See all- K200988Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · cites it directly3descendants
- K231728BiWaze Clear SystemAbmrc, LLC · 2024 · 2 generations on1descendant
- K260604BiWaze Clear SystemAbmrc, LLC · 2026 · 3 generations on0descendants
- K213564BiWaze Clear SystemAbmrc, LLC · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944900 | Therapep | Dhd Diemolding Healthcare Div. | 1995 | — |
| −4 | K991300 | Boeing, Positive Airway Pressure (Pap) Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| −3 | K051964 | Powerneb | Comedica, Inc. | 2005 | — |
| −2 | K124032 | Metaneb | Hill-Rom Services Pte, Ltd. | 2013 | — |
| −1 | K151689 | MetaNeb 4 System | Hill-Rom Services Pte, Ltd. | 2016 | — |
| 0 (this device) | K192143 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | — |
| +1 | K200988 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
| +2 | K231728 | BiWaze Clear System | Abmrc, LLC | 2024 | — |
| +3 | K260604 | BiWaze Clear System | Abmrc, LLC | 2026 | — |
| +2 | K213564 | BiWaze Clear System | Abmrc, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 1 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHJ device
- #1 K260604 BiWaze Clear Systemscore 14.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K124032 | MetanebSummary page 4…(IPPB) Classification Code/Name: NHJ – non-continuous ventilator (IPPB) 21 CFR 868.5905, Class II Predicate Devices: K124032 – Hill-Rom MetaNeb® K151689 – Hill-Rom MetaNeb® K132988 – Vital C… | 2013 |
| * | K151689 | MetaNeb 4 SystemSummary page 4…ventilator (IPPB) 21 CFR 868.5905, Class II Predicate Devices: K124032 – Hill-Rom MetaNeb® K151689 – Hill-Rom MetaNeb® K132988 – Vital Cough Reference Devices: K121955 - Philips Resp… | 2016 |
| * | K132988 | Vital CoughSummary page 4…8.5905, Class II Predicate Devices: K124032 – Hill-Rom MetaNeb® K151689 – Hill-Rom MetaNeb® K132988 – Vital Cough Reference Devices: K121955 - Philips Respironics Cough Assist T70 K89… | 2014 |
| * | K120277 | Vital CoughSummary page 11…Flutter Vital Cough 510(k) Number - K132988 K120277 Regulation Number: 868.5905 CFR classificatio… | 2012 |
| † | K121955 | Coughassist T70 Device | 2012 |
| † | K895485 | Bird (Ipv) Noncontinuous Ventilators | 1989 |
| † | K142888 | Fingertip Pulse Oximeter | 2015 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200988 | Maximus System Class I | 2020 | 3 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2026 | Class I | Z-2549-2026 | Nonconforming Material/Component | 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 ineffective nebulization, which may affect the… |
| May 21, 2026 | Class I | Z-2551-2026 | Nonconforming Material/Component | 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 ineffective nebulization, which may affect the… |
| May 21, 2026 | Class I | Z-2548-2026 | Nonconforming Material/Component | 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 ineffective nebulization, which may affect the… |
| May 21, 2026 | Class I | Z-2550-2026 | Nonconforming Material/Component | 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 ineffective nebulization, which may affect the… |
| Feb 18, 2026 | Class I | Z-1637-2026 | Process control | 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 desaturation), or potential lung tissue… |
| May 30, 2024 | Class I | Z-2321-2024 | Device Design | 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 | Device Design | 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. |
The 5 latest of 7 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K200988Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 19 Class I recalls
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K200988 (Hill-Rom Services Pte, Ltd., 2020) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K124032.
How does its category compare?
All NHJ devicesNHJ Device, Positive Pressure Breathing, Intermittent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NHJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHJ
190in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHJ
11so far in 2026, the most since 2007
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · NHJ
35in 2025
MAUDE reports naming product code NHJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 16 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 3 | 207 | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 3 | 190 | 0 | 3 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 1 | — | 1 (1) | 40 |
| 2025 | 1 | — | 0 | 35 |
| 2026 | 2 | — | 11 (4) | — |
What is it indicated for?
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…
Read the full statement (177 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192143: Maximus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192143
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026