510(k) · Cleared
ClearedRevitalair 430F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxavita Srl · CBF Chamber, Hyperbaric
Cleared on Nov 22, 2019 as substantially equivalent to K072757 (Summit TO Sea, 2008) after an 879-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Nov 22, 2019
- Review
- 879 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011312 (2001). 5 ancestors in all, the oldest K874752 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK011312 BLKS-303 MK Monoplace Hyperbaric SystemKhrunichev State Research & Production Space Centr · 2001
- 2 generations backK060739 Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307Khrunichev State Research & Production Space Centr · 2006
- 1 generation backK072757 Dive and Shallow and Grand DiveSummit TO Sea · 2008
- This deviceK171899 Revitalair 430FOxavita Srl · 2019
- Descendant · cites it directly · 0 of its ownK220290 Revitalair 430+Us Hyperbaric Network · 2023
Most influential descendants
Showing 1 of 1 · See all- K220290Revitalair 430+Us Hyperbaric Network · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011312 | BLKS-303 MK Monoplace Hyperbaric System | Khrunichev State Research & Production Space Centr | 2001 | — |
| −2 | K060739 | Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307 | Khrunichev State Research & Production Space Centr | 2006 | — |
| −1 | K072757 | Dive and Shallow and Grand Dive | Summit TO Sea | 2008 | — |
| 0 (this device) | K171899 | Revitalair 430F | Oxavita Srl | 2019 | — |
| +1 | K220290 | Revitalair 430+ | Us Hyperbaric Network | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 CBF? 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 CBF device
- #1 K240569 FESL FINK Chamber; FEDL FINK Chamber; FETL…score 8.7 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K072757 | Dive and Shallow and Grand DiveSummary page 5…Page 2 of 6 Device Class: Class II Classification Panel: Anesthesiology Devices 5. Legally Marketed Predicate Device(s) K072757, The Dive HD250 and The Grand Dive HD400, SUMMIT TO SEA 6. Indication for Use Statement The intended use of the Portable Hyp… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220290 | Revitalair 430+ | 2023 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K220290 (Us Hyperbaric Network, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CBF devicesCBF Chamber, Hyperbaric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · CBF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CBF
87in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBF
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CBF
25in 2025
MAUDE reports naming product code CBF, 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 | 2 |
| 2008 | 3 | 134 | 2 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 3 | 87 | 0 | 11 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 1 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 1 | — | 0 | 13 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 25 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the Portable Hyperbaric Chamber Revitalair® 430F is to treat acute mountain sickness under the prescription of a health professional. The medical device is designed for use at physician offices and health institutions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171899: Revitalair 430F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171899
Report an extraction error
Are you the manufacturer?
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