510(k) · Cleared
ClearedMoisturestay (Revlon)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Raymond Industrial, Ltd. · IMC Bath, Paraffin
Cleared on Oct 29, 2002 after an 83-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Oct 29, 2002
- Review
- 83 days
- Class
- Class II
- Product code
- IMC
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK022626 Moisturestay (Revlon)Raymond Industrial, Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK093100 Revlon RVSP3501 Spa Moisturestay Paraffin Bath (Type SPB3752EA)Shenzhen Comfort Technology Co., Ltd. · 2009
Most influential descendants
Showing 1 of 1 · See all- K093100Revlon RVSP3501 Spa Moisturestay Paraffin Bath (Type SPB3752EA)Shenzhen Comfort Technology Co., Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022626 | Moisturestay (Revlon) | Raymond Industrial, Ltd. | 2002 | — |
| +1 | K093100 | Revlon RVSP3501 Spa Moisturestay Paraffin Bath (Type SPB3752EA) | Shenzhen Comfort Technology Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IMC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K093100 | Revlon RVSP3501 Spa Moisturestay Paraffin Bath (Type SPB3752EA) | 2009 | 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?
- Of its descendants, K093100 (Shenzhen Comfort Technology Co., Ltd., 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IMC devicesIMC Bath, Paraffin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IMC
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · IMC
Too few IMC 510(k)s in any year since 2007 to give a median.
Recalls per year · IMC
No recall names IMC since 2007.
Adverse event reports per year · IMC
4in 2025
MAUDE reports naming product code IMC, 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 | 7 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Useful in symptomatic relief of pain caused by arthritis, bursitis, and chronic joint inflammation.
Relaxes muscles, relieves stiffness and muscle spasm
Stimulates circulation and for other conditions where heat is indicated.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022626: Moisturestay (Revlon).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022626
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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