510(k) · Cleared
ClearedWright 1000 Monoplace Hyperbaric System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wright Industries · CBF Chamber, Hyperbaric
Cleared on May 28, 1997 as substantially equivalent to K874107 (Hyox Systems C/O Mechidyne Systems, Inc., 1987) after a 726-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- May 28, 1997
- Review
- 726 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K874107 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK874107 H.T.U. (Hyperbaric Therapy Unit)Hyox Systems C/O Mechidyne Systems, Inc. · 1987
- This deviceK952545 Wright 1000 Monoplace Hyperbaric SystemWright Industries · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874107 | H.T.U. (Hyperbaric Therapy Unit) | Hyox Systems C/O Mechidyne Systems, Inc. | 1987 | — |
| 0 (this device) | K952545 | Wright 1000 Monoplace Hyperbaric System | Wright Industries | 1997 | — |
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 |
|---|---|---|---|
| * | K874107 | H.T.U. (Hyperbaric Therapy Unit)Summary page 1…ommon Name: Hyperbaric Chamber. Calssification Name: (PVHO) Pressure Vessel for Human Occupancy. 213 CB¥F, CFR B8. 5470 Predicate Device: HYOX System Limited 510(k) No. K874107 Attention: Christy Foreman :; ;cherly ours— Charles Wright Owner/Operator C. Wright Industries 13760 S. Gramercy Pl. Gardena,… | 1987 |
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?
- Its one ancestor has no 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?
Hyperbaric oxygen therapy (HBO)is a medical treatment where a patient is placed in a specially designed vessel and placed under pressure greater then sea level and breathes 100% oxygen intermittently. Rlveolar oxygen pressure is increased causing a rise in plasma oxygen content which results in enhanced tissue oxygen delivery. the amount of pressure increases and the length of time under pressure are determined by the condition being treated. Treatment…
Read the full statement (163 words)
Hyperbaric oxygen therapy (HBO)is a medical treatment where a patient is placed in a specially designed vessel and placed under pressure greater then sea level and breathes 100% oxygen intermittently. Rlveolar oxygen pressure is increased causing a rise in plasma oxygen content which results in enhanced tissue oxygen delivery. the amount of pressure increases and the length of time under pressure are determined by the condition being treated. Treatment pressures are usually between 2 and 3 times atmospheric. treatment usually lasts from 1 to 2 hours at full pressure.
The following are approved indications:
Air or gas embolism.
Carbon monoxide poisoning and smoke inhalation.
Carbon monoxide complicated by cyanide poisoning.
Clostridial myonecrosis (Gas gangrene).
Crush injury, Compartment syndrome, and other acute traumatic ischemias.
Decompression sickness.
Enhancement of healing in selected problem wounds.
Exceptional blood loss (Anemia)
Necrotizing soft tissue infections (Subcutaneous tissue, Muscle, Fascia).
Osteomyelitis (Refractory).
Radiation tissue damage (Osteoradionecrosis).
Skin grafts and flaps (Compromised).
Thermal burns.
Adjunctive hyperbaric oxygen in intracranial abscess.
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/K952545 · printed Nov 5, 2026
Cite this page
510(k) Report. “K952545: Wright 1000 Monoplace Hyperbaric System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952545
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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