510(k) · Cleared
ClearedOxyHeal 4000 Multiplace Hyperbaric Chamber Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxyheal Medical Systems, Inc. · CBF Chamber, Hyperbaric
Cleared on Mar 22, 2017 as substantially equivalent to K152223 (Oxyheal Medical Systems, Inc., 2016) after a 135-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Mar 22, 2017
- Review
- 135 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K862198 (1986). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK862198 Sigma II - Dual Place Hyperbaric ChamberPerry Baromedical Services · 1986
- 3 generations backK960389 Hyperbaric ChamberTampa Hyperbaric Ent. · 1996
- 2 generations backK011866 Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesHyperbaric Technologies, Inc. · 2002
- 1 generation backK152223 Rectangular Multiplace Hyperbaric Chamber System Product Family with…Oxyheal Medical Systems, Inc. · 2016
- This deviceK163109 OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862198 | Sigma II - Dual Place Hyperbaric Chamber | Perry Baromedical Services | 1986 | — |
| −3 | K960389 | Hyperbaric Chamber | Tampa Hyperbaric Ent. | 1996 | — |
| −2 | K011866 | Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 Series | Hyperbaric Technologies, Inc. | 2002 | — |
| −1 | K152223 | Rectangular Multiplace Hyperbaric Chamber System Product Family with… | Oxyheal Medical Systems, Inc. | 2016 | — |
| 0 (this device) | K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber Family | Oxyheal Medical Systems, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K152223 | Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control…Summary page 4…: II FDA Establishment Registration #: 1000519737 5. Predicate Device OxyHeal® 5000 Rectangular Multiplace Hyperbaric Chamber System Product Family (K152223) 6. Device Description The OxyHeal® 4000 Cylindrical Multiplace Hyperbaric Chamber System Product Family is comprised of a multi… | 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 4 companies; a new generation was cleared every 10.1 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All CBF devicesCBF Chamber, Hyperbaric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 following indications which are listed on the Undersea & Hyperbaric Medical Society (UHMS) web site: www.uhms.org are approved uses of hyperbaric oxygen therapy as defined by the Hyperbaric Oxygen Therapy Committee. . Air or Gas Embolism . Carbon Monoxide Poisoning . Carbon Monoxide Poisoning Complicated by Cyanide Poisoning . Clostridial Myositis and Myonecrosis (Gas Gangrene) . Crush Injury, Compartment Syndrome and Other Acute Ischemias .…
Read the full statement (117 words)
The following indications which are listed on the Undersea & Hyperbaric Medical Society (UHMS) web site: www.uhms.org are approved uses of hyperbaric oxygen therapy as defined by the Hyperbaric Oxygen Therapy Committee.
. Air or Gas Embolism
. Carbon Monoxide Poisoning
. Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
. Clostridial Myositis and Myonecrosis (Gas Gangrene)
. Crush Injury, Compartment Syndrome and Other Acute Ischemias
. Decompression Sickness
. Arterial Insufficiencies
. Central Retinal Artery Occlusion
. Enhancement of Healing in Selected Problem Wounds
. Severe Anemia
. Intracranial Abscess
9. Necrotizing Soft Tissue Infections
10. Osteomyelitis (Refractory)
11. Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
12. Compromised Grafts and Flaps
13. Acute Thermal Burn Injury
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163109 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163109: OxyHeal 4000 Multiplace Hyperbaric Chamber Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163109
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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