510(k) · Cleared
ClearedRSI 4200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reimers Systems, Inc. · CBF Chamber, Hyperbaric
Cleared on Aug 19, 2011 as substantially equivalent to K934164 (Sechrist Industries, Inc., 1995) and 1 other predicate after a 324-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Aug 19, 2011
- Review
- 324 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934164 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK934164 Model 2500E/2500ER Hyperbaric ChamberSechrist Industries, Inc. · 1995
- This deviceK102831 RSI 4200Reimers Systems, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934164 | Model 2500E/2500ER Hyperbaric Chamber | Sechrist Industries, Inc. | 1995 | — |
| 0 (this device) | K102831 | RSI 4200 | Reimers Systems, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (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 |
|---|---|---|---|
| * | K934164 | Model 2500E/2500ER Hyperbaric ChamberSummary page 1…Safety Standard for Health Care Facilities, Chapter 20 Regulation Number: 868.5470 Predicate Devices: 807.92(a)(3) i. Secbrist Industries Model 2500B (K9341 64) ii. Millennium 2000, 2001, 2002, 2003, 2004, 2005 (K041007)… | 1995 |
| * | K041007 | Millenium, Models 2000, 2001 and 2002Summary page 1…68.5470 Predicate Devices: 807.92(a)(3) i. Secbrist Industries Model 2500B (K9341 64) ii. Millennium 2000, 2001, 2002, 2003, 2004, 2005 (K041007) RST 510(K) Submittal… | 2004 |
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?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K934164.
How does its category compare?
All CBF devicesCBF Chamber, Hyperbaric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Specific indications for use of hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society. The current specific indications are: 1. Air or Gas Embolism 2. Carbon Monoxide Poisoning and Smoke Inhalation, Carbon Monoxide Complicated by Cyanide Poisoning 3. Clostridial Myonecrosis (Gas Gangrene) 4. Crush Injury, Compartment Syndrome and Other Acute Traumatic Isehemnias 5.…
Read the full statement (107 words)
Specific indications for use of hyperbaric chambers have been established by the Committee on
Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society. The current specific
indications are:
1. Air or Gas Embolism
2. Carbon Monoxide Poisoning and Smoke Inhalation, Carbon Monoxide Complicated by
Cyanide Poisoning
3. Clostridial Myonecrosis (Gas Gangrene)
4. Crush Injury, Compartment Syndrome and Other Acute Traumatic Isehemnias
5. Decompression Sickness
6. Enhancement of Healing in Selected Problem Wounds
7. Exception Blood Loss (Anemia)
8. Intracranial Abscess
9. Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia)
10. Osteomyelitis (Refractory)
11. Radiation Tissue Damage (Osteoradionecrosis)
12. Skin Grafts and Flaps (Compromised)
13. Thermal Bums
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102831: RSI 4200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102831
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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