510(k) · Cleared
ClearedBLKS-303 MK Monoplace Hyperbaric System
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 18, 2001 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jul 18, 2001
- Review
- 79 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK011312 BLKS-303 MK Monoplace Hyperbaric SystemKhrunichev State Research & Production Space Centr · 2001
- Descendant · cites it directly · 3 of its ownK060739 Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307Khrunichev State Research & Production Space Centr · 2006
- Descendant · 2 generations on · 2 of its ownK072757 Dive and Shallow and Grand DiveSummit TO Sea · 2008
- Descendant · 3 generations on · 1 of its ownK171899 Revitalair 430FOxavita Srl · 2019
- Descendant · 4 generations on · 0 of its ownK220290 Revitalair 430+Us Hyperbaric Network · 2023
Most influential descendants
Showing 4 of 4 · See all- K060739Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307Khrunichev State Research & Production Space Centr · 2006 · cites it directly3descendants
- K072757Dive and Shallow and Grand DiveSummit TO Sea · 2008 · 2 generations on2descendants
- K171899Revitalair 430FOxavita Srl · 2019 · 3 generations on1descendant
- K220290Revitalair 430+Us Hyperbaric Network · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K072757 | Dive and Shallow and Grand Dive | Summit TO Sea | 2008 | — |
| +3 | K171899 | Revitalair 430F | Oxavita Srl | 2019 | — |
| +4 | K220290 | Revitalair 430+ | Us Hyperbaric Network | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060739 | Monoplace Hyperbaric Oxygen Treatment System, Model BLKS-307 | 2006 | 3 |
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?
- Of its descendants, K060739 (Khrunichev State Research & Production Space Centr, 2006) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K011312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011312: BLKS-303 MK Monoplace Hyperbaric System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011312
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026