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 Dec 21, 2022 as substantially equivalent to K200988 (Hill-Rom Services Pte, Ltd., 2020) after a 407-day review. Its family tree reaches back 7 generations to 1995. 2 of the 14 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 21, 2022
- Review
- 407 days
- Class
- Class II
- Product code
- NHJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K944900 (1995). 13 ancestors in all, the oldest K895485 (1989). No later device cites it as a predicate yet. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK944900 TherapepDhd Diemolding Healthcare Div. · 1995
- 6 generations backK991300 Boeing, Positive Airway Pressure (Pap) Therapy DeviceDhd Healthcare Corp. · 1999
- 5 generations backK051964 PowernebComedica, Inc. · 2005
- 4 generations backK124032 MetanebHill-Rom Services Pte, Ltd. · 2013
- 3 generations backK151689 MetaNeb 4 SystemHill-Rom Services Pte, Ltd. · 2016
- 2 generations backK192143 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
- 1 generation backK200988 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
- This deviceK213564 BiWaze Clear SystemAbmrc, LLC · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944900 | Therapep | Dhd Diemolding Healthcare Div. | 1995 | — |
| −6 | K991300 | Boeing, Positive Airway Pressure (Pap) Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| −5 | K051964 | Powerneb | Comedica, Inc. | 2005 | — |
| −4 | K124032 | Metaneb | Hill-Rom Services Pte, Ltd. | 2013 | — |
| −3 | K151689 | MetaNeb 4 System | Hill-Rom Services Pte, Ltd. | 2016 | — |
| −2 | K192143 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
| −1 | K200988 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
| 0 (this device) | 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 |
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? (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.
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 27 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 13 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K200988.
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. 2022, 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 mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis and has the ability to provide supplemental oxygen when used with an oxygen supply.
The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the acute care setting.
The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213564 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213564: 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/K213564
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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