510(k) · Cleared
ClearedVital Cough
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lung Assist, Inc. · NHJ Device, Positive Pressure Breathing, Intermittent
Cleared on Sep 12, 2012 as substantially equivalent to K002598 (J. H. Emerson Co., 2000) after a 226-day review. Its family tree reaches back 1 generation to 2000. 2 of the 8 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Sep 12, 2012
- Review
- 226 days
- Class
- Class II
- Product code
- NHJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002598 (2000). 6 later devices descend from it, 2 citing it directly. 2 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK002598 Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model…J. H. Emerson Co. · 2000
- This deviceK120277 Vital CoughLung Assist, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK132988 Vital CoughLung Assist, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK192143 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK200988 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK231728 BiWaze Clear SystemAbmrc, LLC · 2024
- Descendant · 4 generations on · 0 of its ownK260604 BiWaze Clear SystemAbmrc, LLC · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K132988Vital CoughLung Assist, Inc. · 2014 · cites it directly5descendants
- K192143Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · cites it directly4descendants
- K200988Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · 2 generations on3descendants
- K231728BiWaze Clear SystemAbmrc, LLC · 2024 · 3 generations on1descendant
- K260604BiWaze Clear SystemAbmrc, LLC · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002598 | Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000… | J. H. Emerson Co. | 2000 | — |
| 0 (this device) | K120277 | Vital Cough | Lung Assist, Inc. | 2012 | — |
| +1 | K132988 | Vital Cough | Lung Assist, Inc. | 2014 | — |
| +1 | K192143 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
| +2 | K200988 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
| +3 | K231728 | BiWaze Clear System | Abmrc, LLC | 2024 | — |
| +4 | K260604 | BiWaze Clear System | Abmrc, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2020 | 2 | 2 |
| 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? (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 |
|---|---|---|---|
| * | K002598 | Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual TimingSummary page 2…Substantial Equivalence The Vital Cough is substantially equivalent to the Emerson Cough Assist device (K002598). The modes, frequency, output, and indications for use are equivalent. Differences a… | 2000 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2012, 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 Vital Cough is intended for use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a.facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in a hospital, institutional setting, or home use given adequate training. For use on adult or pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120277 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120277: Vital Cough.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120277
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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