510(k) · Cleared
ClearedClearo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Breas Medical AB · NHJ Device, Positive Pressure Breathing, Intermittent
Cleared on May 16, 2025 as substantially equivalent to K121955 (Respironics, Inc., 2012) after a 273-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- May 16, 2025
- Review
- 273 days
- Class
- Class II
- Product code
- NHJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002598 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK002598 Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model…J. H. Emerson Co. · 2000
- 2 generations backK072292 Negavent Plus Pegaso Cough, Model: DA-3 PlusDima Italia Srl · 2008
- 1 generation backK121955 Coughassist T70 DeviceRespironics, Inc. · 2012
- This deviceK242438 ClearoBreas Medical AB · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002598 | Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000… | J. H. Emerson Co. | 2000 | — |
| −2 | K072292 | Negavent Plus Pegaso Cough, Model: DA-3 Plus | Dima Italia Srl | 2008 | — |
| −1 | K121955 | Coughassist T70 Device | Respironics, Inc. | 2012 | — |
| 0 (this device) | K242438 | Clearo | Breas Medical AB | 2025 | — |
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.
Planning a device in NHJ? 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 |
|---|---|---|---|
| * | K121955 | Coughassist T70 DeviceSummary page 5…21 C.F.R. §868.5905 Class II Product Code(s) NHJ Primary Predicate Device(s) Respironics CoughAssist T70 Device cleared in K121955, Product Code NHJ Reference Device(s) ABMRC LLC BiWaze Cough cleared in K191912, Product Code NHJ Device Description Summary… | 2012 |
| † | K191912 | BiWaze Cough | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K121955.
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. 2025, 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?
Clearo is indicated 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/K242438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242438: Clearo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242438
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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