510(k) · Cleared
ClearedParamed Paraffin Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Divi Intl. Co. · IMC Bath, Paraffin
Cleared on Aug 13, 1999 after a 112-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 13, 1999
- Review
- 112 days
- Class
- Class II
- Product code
- IMC
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
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.
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?
For use in temporary symptomatic relief of minor pain due to medically diagnosed arthritis and bursitis.
Relaxes muscles, aids in the relief of stiff muscles, muscle spasms; helps to stimulate circulation.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991427 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991427: Paramed Paraffin Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991427
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026