510(k) · Cleared
ClearedCoughassist T70 Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · NHJ Device, Positive Pressure Breathing, Intermittent
Cleared on Dec 14, 2012 as substantially equivalent to K002598 (J. H. Emerson Co., 2000) and 1 other predicate after a 164-day review. Its family tree reaches back 2 generations to 2000. 3 of the 17 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it.
- Decided
- Dec 14, 2012
- Review
- 164 days
- Class
- Class II
- Product code
- NHJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002598 (2000). 14 later devices descend from it, 6 citing it directly. 3 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK002598 Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model…J. H. Emerson Co. · 2000
- 1 generation backK072292 Negavent Plus Pegaso Cough, Model: DA-3 PlusDima Italia Srl · 2008
- This deviceK121955 Coughassist T70 DeviceRespironics, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK162877 VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · cites it directly · 4 of its ownK122111 Respironics Simplyclear DeviceRespironics, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK140598 Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough PercDima Italia Srl · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 14 · See all- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · cites it directly6descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 2 generations on5descendants
- K122111Respironics Simplyclear DeviceRespironics, Inc. · 2012 · cites it directly4descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · 3 generations on2descendants
- K140598Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough PercDima Italia Srl · 2014 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K121955 | Coughassist T70 Device | Respironics, Inc. | 2012 | — |
| +1 | K162877 | VOCSN Unified Respiratory System | Ventec Life Systems, Inc. | 2017 | Class I |
| +2 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +1 | K122111 | Respironics Simplyclear Device | Respironics, Inc. | 2012 | — |
| +3 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
| +1 | K140598 | Pegaso Cough, Pegaso a-Cough, Pegaso a-Cough Perc | Dima Italia Srl | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 1 |
| 2019 | 1 | 1 |
| 2020 | 1 | 0 |
| 2021 | 1 | 1 |
| 2024 | 3 | 0 |
| 2025 | 3 | 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.
3 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? (2)
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…standards). Predicate Device Name(s) and Emerson CoughAssist, Model CA-3000 - 510(k) numbers: K002598 Dima Italia Negavent DA-3 Plus Pegaso - ________________________K072292… | 2000 |
| * | K072292 | Negavent Plus Pegaso Cough, Model: DA-3 PlusSummary page 2…k) numbers: K002598 Dima Italia Negavent DA-3 Plus Pegaso - ________________________K072292 Reason for submission: Device modifications Description of Device The Philips Respironics CoughAssist… | 2008 |
What descends from it? (14)
See all 146 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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.
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K162877 (Ventec Life Systems, Inc., 2017) has gone furthest, with 6 descendants of its own.
- 6 other devices also cite its predicate K002598.
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 Philips Respironics CoughAssist T70 is intended for use on adult or pediatric patients unable to cough or clear secretions effectively. It may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. The device is intended to be used in the hospital, institutional environment or in the home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121955: Coughassist T70 Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121955
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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