510(k) · Cleared
ClearedBiWaze Clear System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abmrc, LLC · NHJ Device, Positive Pressure Breathing, Intermittent
Cleared on Aug 24, 2026 as substantially equivalent to K231728 (Abmrc, LLC, 2024) after a 181-day review. Its family tree reaches back 8 generations to 1995. 2 of the 15 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 24, 2026
- Review
- 181 days
- Class
- Class II
- Product code
- NHJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K944900 (1995). 14 ancestors in all, the oldest K895485 (1989). No later device cites it as a predicate yet. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK944900 TherapepDhd Diemolding Healthcare Div. · 1995
- 7 generations backK991300 Boeing, Positive Airway Pressure (Pap) Therapy DeviceDhd Healthcare Corp. · 1999
- 6 generations backK051964 PowernebComedica, Inc. · 2005
- 5 generations backK124032 MetanebHill-Rom Services Pte, Ltd. · 2013
- 4 generations backK151689 MetaNeb 4 SystemHill-Rom Services Pte, Ltd. · 2016
- 3 generations backK192143 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
- 2 generations backK200988 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
- 1 generation backK231728 BiWaze Clear SystemAbmrc, LLC · 2024
- This deviceK260604 BiWaze Clear SystemAbmrc, LLC · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K944900 | Therapep | Dhd Diemolding Healthcare Div. | 1995 | — |
| −7 | K991300 | Boeing, Positive Airway Pressure (Pap) Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| −6 | K051964 | Powerneb | Comedica, Inc. | 2005 | — |
| −5 | K124032 | Metaneb | Hill-Rom Services Pte, Ltd. | 2013 | — |
| −4 | K151689 | MetaNeb 4 System | Hill-Rom Services Pte, Ltd. | 2016 | — |
| −3 | K192143 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
| −2 | K200988 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
| −1 | K231728 | BiWaze Clear System | Abmrc, LLC | 2024 | — |
| 0 (this device) | K260604 | BiWaze Clear System | Abmrc, LLC | 2026 | — |
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 |
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 K253001 KT Airway Clearance Device II (KT-3); KT…score 13.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K231728 | BiWaze Clear SystemSummary page 5…Noncontinuous ventilator (IPPB) Classification: NHJ, 868.5905 Predicate Device: BiWaze Clear System, ABMRC LLC, K231728 Common/Usual Name: Noncontinuous ventilator (IPPB) Classification: NHJ, 868.5905… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 14 ancestors have a recall of any class; 2 have a Class I recall.
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. 2026, 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 BiWaze® Clear System is indicated for the loosening and mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and can provide supplemental oxygen when used with an oxygen supply. The system provides three therapies: Positive Expiratory Pressure (PEP), Oscillation (OSC), and delivery of saline via integrated nebulizer (NEB). The BiWaze Clear System is for use on adult or pediatric patients in acute…
Read the full statement (129 words)
The BiWaze® Clear System is indicated for the loosening and mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and can provide supplemental oxygen when used with an oxygen supply. The system provides three therapies: Positive Expiratory Pressure (PEP), Oscillation (OSC), and delivery of saline via integrated nebulizer (NEB).
The BiWaze Clear System is for use on adult or pediatric patients in acute care (aged 2 years and older) and home care environments (aged 5 years and older).
The BiWaze Clear System is compatible with various patient interfaces including face mask, mouthpiece, a trach adapter for connection to an endotracheal or tracheostomy tube in acute and home care settings.
The BiWaze Clear System may be used in-line with a ventilator in acute care environments only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260604: BiWaze Clear System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260604
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026