510(k) · Cleared
ClearedDive and Shallow and Grand Dive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Summit TO Sea · CBF Chamber, Hyperbaric
Cleared on Feb 8, 2008 as substantially equivalent to K874752 (Hyperbaric Aerobics, Ltd., 1988) and 2 other predicates after a 134-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Feb 8, 2008
- Review
- 134 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K011312 (2001). 4 ancestors in all, the oldest K874752 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK011312 BLKS-303 MK Monoplace Hyperbaric SystemKhrunichev State Research & Production Space Centr · 2001
- 1 generation backK060739 Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307Khrunichev State Research & Production Space Centr · 2006
- This deviceK072757 Dive and Shallow and Grand DiveSummit TO Sea · 2008
- Descendant · cites it directly · 1 of its ownK171899 Revitalair 430FOxavita Srl · 2019
- Descendant · 2 generations on · 0 of its ownK220290 Revitalair 430+Us Hyperbaric Network · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011312 | BLKS-303 MK Monoplace Hyperbaric System | Khrunichev State Research & Production Space Centr | 2001 | — |
| −1 | K060739 | Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307 | Khrunichev State Research & Production Space Centr | 2006 | — |
| 0 (this device) | K072757 | Dive and Shallow and Grand Dive | Summit TO Sea | 2008 | — |
| +1 | K171899 | Revitalair 430F | Oxavita Srl | 2019 | — |
| +2 | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K874752 | Gamow Hyperbaric BagSummary page 1…r (868.5470, Product Code CBF) This submission is using the Gamow BagIHTI Model-2, manufactured by HTI as the substantially equivalent devices. The FDA 510K numbers are K874752A for the Gamow bag and KO01409 for the HTI Model-2. Also, the BLKS-307 Monoplace Hyperbaric Oxygen Treatment System is used as a… | 1988 |
| * | K001409 | Gamow Bag, Hyper Oxy, Hyper Oxy P/T, Pressure-CizerSummary page 3…ly Marketed Devices: There is no significance difference between The Shallow Dive, The Dive, The Grand Dive and the predicate Gamow Bag K874752A and HTI Model-2 K001409. {$ 5. Ve ,6avlcss DEPARTh4ENT OFHEAL,TH &HUMAN SERVICES… | 2000 |
| * | K060739 | Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307Summary page 1…w bag and KO01409 for the HTI Model-2. Also, the BLKS-307 Monoplace Hyperbaric Oxygen Treatment System is used as a substantial equivalent device with the FDA 510 number K060739. Device Description Hyperbaric Dive chambers are mild hyperbaric chambers for pressures less than 5 PSI. This chamber is design… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171899 | Revitalair 430F | 2019 | 1 |
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 7 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K171899 (Oxavita Srl, 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K874752.
How does its category compare?
All CBF devicesCBF Chamber, Hyperbaric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Dive Series Hyperbaric Chambers are rugged and portable, intended to be used to treat:
Acute Mountain sickness (AMS)
as prescribed by or under the direction of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072757: Dive and Shallow and Grand Dive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072757
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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