510(k) · Cleared
ClearedRachel's Remedy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rachel'S Remedies, LLC · IMA Pack, Heat, Moist
Cleared on May 22, 2015 as substantially equivalent to K832803 (Electro-Med Health Industries, Inc., 1983) and 1 other predicate after a 120-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- May 22, 2015
- Review
- 120 days
- Class
- Class I
- Product code
- IMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K832803 (1983). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK832803 Steam Pak Moist HeatElectro-Med Health Industries, Inc. · 1983
- This deviceK150139 Rachel's RemedyRachel'S Remedies, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832803 | Steam Pak Moist Heat | Electro-Med Health Industries, Inc. | 1983 | — |
| 0 (this device) | K150139 | Rachel's Remedy | Rachel'S Remedies, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 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 IMA? 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? (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 |
|---|---|---|---|
| * | K832803 | Steam Pak Moist HeatSummary page 5…k. Since our indications for use exceed this, we have submitted valid scientific evidence to support and verify our indications for use. 510(K) Number K832803 K841698 Device Name Steam Pak Moist Heat Heat Pack Applicant… | 1983 |
| * | K841698 | Heat PackSummary page 5…exceed this, we have submitted valid scientific evidence to support and verify our indications for use. 510(K) Number K832803 K841698 Device Name Steam Pak Moist Heat Heat Pack Applicant Electro‐Med Health Indus… | 1984 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All IMA devicesIMA Pack, Heat, Moist: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · IMA
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · IMA
Too few IMA 510(k)s in any year since 2007 to give a median.
Recalls per year · IMA
No recall names IMA since 2007.
Adverse event reports per year · IMA
2in 2024
MAUDE reports naming product code IMA, 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 | 0 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Rachel's Remedy is designed to provide moist heat and/or cooling relief to relieve symptoms associated with clogged ducts, mastitis, milk blisters, blebs and engorgement. It is also designed to encourage let-down and milk flow, and can help prevent mastitis.
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/K150139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150139: Rachel's Remedy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150139
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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