510(k) · Cleared
ClearedParaspa Paraffin Bath, Paraspap Mini, Paraspa Ultra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Homedics, Inc. · IMC Bath, Paraffin
Cleared on Aug 10, 2000 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Aug 10, 2000
- Review
- 52 days
- Class
- Class II
- Product code
- IMC
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK001860 Paraspa Paraffin Bath, Paraspap Mini, Paraspa UltraHomedics, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK013707 Softique, Model GI 11001Global TV Concepts, Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK013328 Remington Paraffin Spa, Models HS-200. PFS-600Remington Products Company, LLC · 2001
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001860 | Paraspa Paraffin Bath, Paraspap Mini, Paraspa Ultra | Homedics, Inc. | 2000 | — |
| +1 | K013707 | Softique, Model GI 11001 | Global TV Concepts, Ltd. | 2002 | — |
| +1 | K013328 | Remington Paraffin Spa, Models HS-200. PFS-600 | Remington Products Company, LLC | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K013707 (Global TV Concepts, Ltd., 2002) 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 | — |
https://510kreport.com/device/K001860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001860: Paraspa Paraffin Bath, Paraspap Mini, Paraspa Ultra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001860
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026