510(k) · Cleared
ClearedAtlantis Hyperbaric Chamber Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Providence Global Medical, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Dec 17, 2009 as substantially equivalent to K082351 (Level-5, Inc., 2009) after a 142-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.
- Decided
- Dec 17, 2009
- Review
- 142 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082351 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK082351 Neptune Hyperbaric VentilatorLevel-5, Inc. · 2009
- This deviceK092264 Atlantis Hyperbaric Chamber VentilatorProvidence Global Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK122560 Versalvent Model V1 Hyperbaric Chamber Ventilator Model V1Pan-America Hyperbarics, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K122560Versalvent Model V1 Hyperbaric Chamber Ventilator Model V1Pan-America Hyperbarics, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082351 | Neptune Hyperbaric Ventilator | Level-5, Inc. | 2009 | — |
| 0 (this device) | K092264 | Atlantis Hyperbaric Chamber Ventilator | Providence Global Medical, Inc. | 2009 | — |
| +1 | K122560 | Versalvent Model V1 Hyperbaric Chamber Ventilator Model V1 | Pan-America Hyperbarics, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 CBK? 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 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 |
|---|---|---|---|
| * | K082351 | Neptune Hyperbaric VentilatorSummary page 4…inuous, Facility Use Classification Name Continuous Ventilator (21 C.F.R. § 868.5895) Product Code CBK Predicate Device Level-5, Inc.’s Neptune Hyperbaric Ventilator (K082351) Indications for Use ' The Atlantis Hyperbaric Ventilator is indicated for use in patients in respiratory failure or who otherwi… | 2009 |
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 |
|---|---|---|---|
| K122560 | Versalvent Model V1 Hyperbaric Chamber Ventilator Model V1 | 2013 | 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?
- Its one ancestor has no recall.
- Of its descendants, K122560 (Pan-America Hyperbarics, Inc., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The Atlantis Hyperbaric Ventilator is indicated for use with pediatric and adult patients in
respiratory failure or any other specific patient breathing requirements, as determined by the
attending physician, when the patient is placed inside a hyperbaric chamber for prescribed
therapy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092264: Atlantis Hyperbaric Chamber Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092264
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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