510(k) · Cleared
ClearedPegaso V, Negavent Respirator, Model: DA-3 Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dima Italia Srl · BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Cleared on May 29, 2008 as substantially equivalent to K910947 (Lifecare Services, Inc., 1991) after a 287-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- May 29, 2008
- Review
- 287 days
- Class
- Class II
- Product code
- BYT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910947 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK910947 Nev-10 Negative Pressure VentilatorLifecare Services, Inc. · 1991
- This deviceK072290 Pegaso V, Negavent Respirator, Model: DA-3 PlusDima Italia Srl · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910947 | Nev-10 Negative Pressure Ventilator | Lifecare Services, Inc. | 1991 | — |
| 0 (this device) | K072290 | Pegaso V, Negavent Respirator, Model: DA-3 Plus | Dima Italia Srl | 2008 | — |
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? (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 |
|---|---|---|---|
| * | K910947 | Nev-10 Negative Pressure VentilatorSummary page 1…BYT Common Name: External Negative Pressure Ventilator SE Predicate: Lifecare Services Inc. NEV-100, Non-invasive Extrathoracic Ventilator K910947 868.5935 Device Description: The Pegaso V is an assisted/controlled non-invasive ventilation system. It can work… | 1991 |
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?
- Its one ancestor has no 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?
The New Negavent Ventilator DA-3 Plus Pegaso V is a timed-cycled, pressure ventilator that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient. The ventilator works with a cuirass, poncho, or ventilating chamber (Porta-Lung).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072290 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072290: Pegaso V, Negavent Respirator, Model: DA-3 Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072290
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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