510(k) · Cleared
ClearedEmerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual Timing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. H. Emerson Co. · NHJ Device, Positive Pressure Breathing, Intermittent
Cleared on Nov 22, 2000 after a 93-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 25 devices in its family, counting itself, have a Class I recall. 24 later devices descend from it.
- Decided
- Nov 22, 2000
- Review
- 93 days
- Class
- Class II
- Product code
- NHJ
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 7 citing it directly. 5 of the 25 devices in this family, counting this one, have a Class I recall.
- This deviceK002598 Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model…J. H. Emerson Co. · 2000
- Descendant · cites it directly · 16 of its ownK072292 Negavent Plus Pegaso Cough, Model: DA-3 PlusDima Italia Srl · 2008
- Descendant · cites it directly · 14 of its ownK121955 Coughassist T70 DeviceRespironics, Inc. · 2012
- Descendant · 2 generations on · 6 of its ownK162877 VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Recalled (Class I)
- Descendant · cites it directly · 6 of its ownK120277 Vital CoughLung Assist, Inc. · 2012
- Descendant · 3 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 24 · See all- K072292Negavent Plus Pegaso Cough, Model: DA-3 PlusDima Italia Srl · 2008 · cites it directly16descendants
- K121955Coughassist T70 DeviceRespironics, Inc. · 2012 · cites it directly14descendants
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations on6descendants
- K120277Vital CoughLung Assist, Inc. · 2012 · cites it directly6descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002598 | Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000… | J. H. Emerson Co. | 2000 | — |
| +1 | K072292 | Negavent Plus Pegaso Cough, Model: DA-3 Plus | Dima Italia Srl | 2008 | — |
| +1 | K121955 | Coughassist T70 Device | Respironics, Inc. | 2012 | — |
| +2 | K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | 2017 | Class I |
| +1 | K120277 | Vital Cough | Lung Assist, Inc. | 2012 | — |
| +3 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2017 | 1 | 1 |
| 2019 | 1 | 1 |
| 2020 | 3 | 2 |
| 2021 | 1 | 1 |
| 2022 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (24)
See all 247 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072292 | Negavent Plus Pegaso Cough, Model: DA-3 Plus | 2008 | 16 |
| K121955 | Coughassist T70 Device | 2012 | 14 |
| K120277 | Vital Cough | 2012 | 6 |
| K122111 | Respironics Simplyclear Device | 2012 | 4 |
| K140598 | Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough Perc | 2014 | 1 |
| K140605 | Minipegaso Cough, Minipegaso a-Cough, Minipegaso a-Coug Perc | 2014 | 0 |
| K113549 | Comfort Cough | 2013 | 0 |
Has anything in its family been recalled? (5 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.
- K192143Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 17 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K200988Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 19 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K072292 (Dima Italia Srl, 2008) has gone furthest, with 16 descendants of its own.
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.
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) | — |
https://510kreport.com/device/K002598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002598: Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual Timing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002598
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026