510(k) · Cleared
ClearedFlexi-Lite, Model FL-V1.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Performance Hyperbarics · CBF Chamber, Hyperbaric
Cleared on Nov 17, 2005 as substantially equivalent to K874752 (Hyperbaric Aerobics, Ltd., 1988) and 1 other predicate after a 141-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.
- Decided
- Nov 17, 2005
- Review
- 141 days
- Class
- Class II
- Product code
- CBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K874752 (1988). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K101262Flexi-LitePressure-Tech, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874752 | Gamow Hyperbaric Bag | Hyperbaric Aerobics, Ltd. | 1988 | — |
| 0 (this device) | K051759 | Flexi-Lite, Model FL-V1.2 | Performance Hyperbarics | 2005 | — |
| +1 | K101262 | Flexi-Lite | Pressure-Tech, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K874752 | Gamow Hyperbaric BagSummary page 1…73 CBF Device: Flexible Hyperbaric Chamber with Air Compressor Predicate Devices: HTL - Gamnow Bag -K874752A HTI - Mild Hyperbaric Chamber -KOO 1409 Device Description The Flexi-Lite flexible hype… | 1988 |
| * | K001409 | Gamow Bag, Hyper Oxy, Hyper Oxy P/T, Pressure-CizerSummary page 3…son To Predicate Devices Attribute Gamow HTI Model-2 HTI Model-3 Flexi-Lite K874752A K001409 K001409 K051759 Intended Use Acute Mountain Acute Mountain Acute Mountain Acute Mo… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101262 | Flexi-Lite | 2010 | 0 |
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?
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 Flexi-Lite Hyperbaric chamber is a rugged & portable hyperbaric chamber intended to be used in treating mild symptoms consistent with Acute Mountain Sickness (AMS) as prescribed by or under the direction of a physician. Caution: Federal law restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051759: Flexi-Lite, Model FL-V1.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051759
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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