510(k) · Cleared
ClearedGSP1 - Gas Selection Panel
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 Oct 23, 1996 as substantially equivalent to K954387 (Reimers Systems, Inc., 1995) after a 92-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Oct 23, 1996
- Review
- 92 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954387 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK954387 T Class Hyperbaric FacilitiesReimers Systems, Inc. · 1995
- This deviceK962869 GSP1 - Gas Selection PanelReimers Systems, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954387 | T Class Hyperbaric Facilities | Reimers Systems, Inc. | 1995 | — |
| 0 (this device) | K962869 | GSP1 - Gas Selection Panel | Reimers Systems, Inc. | 1996 | — |
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 |
|---|---|---|---|
| * | K954387 | T Class Hyperbaric FacilitiesSummary page 2…: The GSP1 is substantially equivalent to the air/oxygen switch-over circuit found in larger hyperbaric chamber systems, such as the RSI T-Class Hyperbaric Facilities (K954387) as the following table indicates: Parameter RSI T-Class air/oxygen switch-over circuit GSP1- Gas Selection Panel Number of g… | 1995 |
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.
- 3 other devices also cite its predicate K954387.
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 RSI GSP1 Gas Selection Panel is intended for use with hyperbaric oxygen (HBO) treatment gas systems whenever there is a need to select between two available gases. This typically includes support for monoplace chamber pressurization/ventilation systems and patient breathing gas systems supporting masks and hoods.
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/K962869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962869: GSP1 - Gas Selection Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962869
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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