510(k) · Cleared
ClearedFESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fink Engineering Pty, Ltd. · CBF Chamber, Hyperbaric
Cleared on Nov 21, 2024 as substantially equivalent to K031649 (Fink Engineering Pty, Ltd., 2003) after a 266-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Nov 21, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930748 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK930748 Sigma MP Multiplace Hyperbaric ChamberPerry Baromedical Services · 1993
- 1 generation backK031649 SL8/DL8/TL20 Hyperbaric Oxygen Treatment FacilitiesFink Engineering Pty, Ltd. · 2003
- This deviceK240569 FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930748 | Sigma MP Multiplace Hyperbaric Chamber | Perry Baromedical Services | 1993 | — |
| −1 | K031649 | SL8/DL8/TL20 Hyperbaric Oxygen Treatment Facilities | Fink Engineering Pty, Ltd. | 2003 | — |
| 0 (this device) | K240569 | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber | Fink Engineering Pty, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 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 K220290 Revitalair 430+score 6.2 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K031649 | SL8/DL8/TL20 Hyperbaric Oxygen Treatment FacilitiesSummary page 5…ication Name 21 CRF 868.5470 Hyperbaric chamber Regulatory Class: II Product Code: CBF 3. PREDICATE DEVICE Predicate Device: K031649 SL8/DL8/TL20 Hyperbaric Oxygen Treatment Facilities Reference Device: K152223 OxyHeal 5000 Rectangular Multiplace Hyperbaric Cham… | 2003 |
| † | K152223 | Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control… | 2016 |
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.
What does this lineage say?
- The line of descent spans 31 years and passes through 2 companies; a new generation was cleared every 21.0 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K031649.
How does its category compare?
All CBF devicesCBF Chamber, Hyperbaric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 conditions listed as appropriate for the use of HBO recognized by the Undersea & Hyperbaric Medical Society's (UHMS) Hyperbaric Oxygen Therapy Committee Report, as follows: 1. Air or gas embolism 2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning 3. Clostridial myonecrosis and myonecrosis 4. Crush injuries, compartment syndrome, and other acute traumatic ischemias 5. Decompression sickness 6. Enhancement of…
Read the full statement (104 words)
The conditions listed as appropriate for the use of HBO recognized by the Undersea & Hyperbaric Medical Society's (UHMS) Hyperbaric Oxygen Therapy Committee Report, as follows:
1. Air or gas embolism
2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
3. Clostridial myonecrosis and myonecrosis
4. Crush injuries, compartment syndrome, and other acute traumatic ischemias
5. Decompression sickness
6. Enhancement of healing of selected problem wounds
7. Exceptional blood loss anemia
8. Necrotizing soft tissue infections
9. Osteomyelitis (refractory)
10. Delayed radiation injuries (soft tissue and bony necrosis)
11. Compromised grafts and flaps
12. Acute Thermal Burn Injury
13. Intracranial abscess
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240569 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240569: FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240569
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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