510(k) · Cleared
ClearedMillenium, Models 2000, 2001 and 2002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hyperbaric For Life, LLC · CBF Chamber, Hyperbaric
Cleared on Nov 15, 2004 after a 210-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Nov 15, 2004
- Review
- 210 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK041007 Millenium, Models 2000, 2001 and 2002Hyperbaric For Life, LLC · 2004
- Descendant · cites it directly · 0 of its ownK102831 RSI 4200Reimers Systems, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K102831RSI 4200Reimers Systems, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041007 | Millenium, Models 2000, 2001 and 2002 | Hyperbaric For Life, LLC | 2004 | — |
| +1 | K102831 | RSI 4200 | Reimers Systems, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102831 | RSI 4200 | 2011 | 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?
- Of its descendants, K102831 (Reimers Systems, Inc., 2011) has gone furthest, with 0 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 Hyperbaric Oxygen Therapy in the current edition of the Undersea and Hyperbaric and Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1998) 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…
Read the full statement (97 words)
The conditions listed as appropriate for the use of Hyperbaric Oxygen Therapy in the current edition of the Undersea and Hyperbaric and Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1998) 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 bone necrosis)
Skin grafts and flaps (compromised)
Thermal burns
Intracranial abscess
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041007: Millenium, Models 2000, 2001 and 2002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041007
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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