510(k) · Cleared
ClearedRTX Respirator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medivent Limited · BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Cleared on Oct 8, 2008 as substantially equivalent to K924341 (Respironics, Inc., 1993) and 2 other predicates after a 26-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Oct 8, 2008
- Review
- 26 days
- Class
- Class II
- Product code
- BYT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K841529 (1984). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK841529 Siemens-Elema Ventilator 900CSiemens Elema AB · 1984
- This deviceK082657 RTX RespiratorMedivent Limited · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K841529 | Siemens-Elema Ventilator 900C | Siemens Elema AB | 1984 | — |
| 0 (this device) | K082657 | RTX Respirator | Medivent Limited | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 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.
Planning a device in BYT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K924341 | Hayek Oscillator (TM)Summary page 1…evices The RTX Respirator is substantially equivalent to the following devices: 510(k) Number Device Manufacturer K924341 Hayek Oscillator Respironics K841529 Servo Ventilator 900C… | 1993 |
| * | K841529 | Siemens-Elema Ventilator 900CSummary page 1…evices: 510(k) Number Device Manufacturer K924341 Hayek Oscillator Respironics K841529 Servo Ventilator 900C Siemens K884098 Thairapy TM Bronchial Drainage Or… | 1984 |
| * | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101Summary page 1…Manufacturer K924341 Hayek Oscillator Respironics K841529 Servo Ventilator 900C Siemens K884098 Thairapy TM Bronchial Drainage Originally manufactured by System, Model 101 now know… | 1988 |
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?
- None of the 3 ancestors has a recall.
How does its category compare?
All BYT devicesBYT Ventilator, External Body, Negative Pressure, Adult (Cuirass): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · BYT
2in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · BYT
Too few BYT 510(k)s in any year since 2007 to give a median.
Recalls per year · BYT
No recall names BYT since 2007.
Adverse event reports per year · BYT
1in 2018
MAUDE reports naming product code BYT, 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 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1) Ventilation -
The RTX Respirator is indicated for external ventilation of the lungs resulting in gas exchange.
2) Secretion Clearance -
Also for use in assisting patients with secretion clearance management as indicated by standard medical convention
The RTX Respirator is for use in adult and pediatric patient populations. The RTX is not for use in out-of-hospital transport. For prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082657: RTX Respirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082657
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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