510(k) · Cleared
ClearedPan-America Hyperbarics Hyperbaric Chamber System, Model Pah-M3+1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pan-America Hyperbarics, Inc. · CBF Chamber, Hyperbaric
Cleared on Oct 24, 2002 as substantially equivalent to K862198 (Perry Baromedical Services, 1986) and 1 other predicate after a 155-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Oct 24, 2002
- Review
- 155 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K862198 (1986). No later device cites it as a predicate yet.
- Root · 2 generations backK862198 Sigma II - Dual Place Hyperbaric ChamberPerry Baromedical Services · 1986
- 1 generation backK983648 Sigma Plus/ II Multiplace Hyperbaric SystemPerry Baromedical Services · 1999
- This deviceK021690 Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-M3+1Pan-America Hyperbarics, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862198 | Sigma II - Dual Place Hyperbaric Chamber | Perry Baromedical Services | 1986 | — |
| −1 | K983648 | Sigma Plus/ II Multiplace Hyperbaric System | Perry Baromedical Services | 1999 | — |
| 0 (this device) | K021690 | Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-M3+1 | Pan-America Hyperbarics, Inc. | 2002 | — |
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? (2)
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 |
|---|---|---|---|
| * | K862198 | Sigma II - Dual Place Hyperbaric ChamberSummary page 1…c Chamber CLASSIFICATION: 73 CBF, 21 CFR 868.5470 ESTABLISHMENT REGISTRATION NUMBER: Pending CLAIMED PREDICATE DEVICE(S): Perry Sigma II Hyperbaric Chamber - K862198 Perry Sigma Plus/lI Hyperbaric Chamber - K983648 ADDRESS OF MANUFACTURER: Pan-America Hyperbarics, Inc.… | 1986 |
| * | K983648 | Sigma Plus/ II Multiplace Hyperbaric SystemSummary page 1…LISHMENT REGISTRATION NUMBER: Pending CLAIMED PREDICATE DEVICE(S): Perry Sigma II Hyperbaric Chamber - K862198 Perry Sigma Plus/lI Hyperbaric Chamber - K983648 ADDRESS OF MANUFACTURER: Pan-America Hyperbarics, Inc. No.9, Lane 12,… | 1999 |
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 16 years and passes through 2 companies; a new generation was cleared every 12.3 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K862198.
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 HBO in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:
1. Air or gas embolism
2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
3. Clostridial myositis and myonecrosis
4. Crush injury, compartment syndrome, and other acute traumatic ischemias
5. Decompression sickness
6. Enhanced healing of selected problem wounds
7. Exceptional blood loss anemia
8. Necrotizing soft tissue infections
9. Osteomyelitis (refractory)
10. Delayed radiation injury (soft tissue and bony necrosis)
11. Skin grafts and flaps (compromised)
12. Thermal burns
13. Intracranial abscess
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021690 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021690: Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-M3+1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021690
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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