510(k) · Cleared
ClearedMonoplace Hyperbaric Oxygen Treatment System, Model BLKS-307
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Khrunichev State Research & Production Space Centr · CBF Chamber, Hyperbaric
Cleared on Jul 21, 2006 as substantially equivalent to K011312 (Khrunichev State Research & Production Space Centr, 2001) after a 123-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Jul 21, 2006
- Review
- 123 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011312 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011312 BLKS-303 MK Monoplace Hyperbaric SystemKhrunichev State Research & Production Space Centr · 2001
- This deviceK060739 Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307Khrunichev State Research & Production Space Centr · 2006
- Descendant · cites it directly · 2 of its ownK072757 Dive and Shallow and Grand DiveSummit TO Sea · 2008
- Descendant · 2 generations on · 1 of its ownK171899 Revitalair 430FOxavita Srl · 2019
- Descendant · 3 generations on · 0 of its ownK220290 Revitalair 430+Us Hyperbaric Network · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011312 | BLKS-303 MK Monoplace Hyperbaric System | Khrunichev State Research & Production Space Centr | 2001 | — |
| 0 (this device) | 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 | — |
| +2 | K171899 | Revitalair 430F | Oxavita Srl | 2019 | — |
| +3 | K220290 | Revitalair 430+ | Us Hyperbaric Network | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K011312 | BLKS-303 MK Monoplace Hyperbaric SystemSummary page 2…Khrunichev Parameters Units BLKS-303MK Khrunichev K011312. BLKS-307 Internal Diameter In (mm) 28.7 (730) 42,1 (1080) Length… | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072757 | Dive and Shallow and Grand Dive | 2008 | 2 |
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, K072757 (Summit TO Sea, 2008) has gone furthest, with 2 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.
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 conditions listed as appropriate for the use of the Hyperbaric Oxygen Therapy in the current edition of Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1999) are as follows: * Air or gas embolism * Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning * Clostridial myositis and myonecrosis * Crush injury, compartment syndrome, and other acute traumatic ischemias *…
Read the full statement (109 words)
The conditions listed as appropriate for the use of the Hyperbaric Oxygen Therapy in the current edition of Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:
* Air or gas embolism
* Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
* Clostridial myositis and myonecrosis
* Crush injury, compartment syndrome, and other acute traumatic ischemias
* Decompression sickness
* Enhanced healing of selected problem wounds
* Exceptional blood loss anemia
* Necrotizing soft tissue infections
* Osteomyelitis (refractory)
* Delayed radiation injury (soft tissue and bony necrosis)
* Skin grafts and flaps (compromised)
* Thermal burns
* Intracranial abscess
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060739 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060739: Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060739
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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