510(k) · Cleared
ClearedMsi I2010 Dual Place Hyperbaric Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mechidyne Systems, Inc. · CBF Chamber, Hyperbaric
Cleared on Feb 26, 2003 after a 233-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 26, 2003
- Review
- 233 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
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?
1 Air or Gas Embolism
2 Carbon Monoxide Poisoning
Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
3 Clostridal Myositis and Myonecrosis (Gas Gangrene)
4 Crush Iniury, Compartment Syndrome, and other Acute Traumatic lschemias
5 Decompression Sickness
6 Enhancement of Healing in Selected Problem Wounds
7 Exceptional Blood Loss <Anemia)
8 Intracranial Abscess
9 Necrotizinq Soft Tissue Infections
10 0st eomye Iit is (Refractory)
11 Delayed Radiation Injury (Soft Tissue and Bony Necrosis
12 Skin Grafts & Flaps (Compromised)
13 Thermal Burns
These are the indicated uses by the Undersea & Hyperbaric Medical Society.
The device is designed to be used for the indicated uses only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022214 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022214: Msi I2010 Dual Place Hyperbaric Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022214
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026