510(k) · Cleared
ClearedWorry-Remover Irrigator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corisen Group, Ltd. · HED Douche Apparatus, Vaginal, Therapeutic
Cleared on Apr 22, 2003 as substantially equivalent to K000736 (Goomi Ehwa, Inc., 2000) and 1 other predicate after a 106-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Apr 22, 2003
- Review
- 106 days
- Class
- Class I
- Product code
- HED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902830 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK902830 Peri-BottleOrion Life Systems, Inc. · 1990
- This deviceK030056 Worry-Remover IrrigatorCorisen Group, Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902830 | Peri-Bottle | Orion Life Systems, Inc. | 1990 | — |
| 0 (this device) | K030056 | Worry-Remover Irrigator | Corisen Group, Ltd. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 HED? 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 |
|---|---|---|---|
| * | K000736 | LA JoieSummary page 1…assification DOUCHE APPRATUS, VAGINAL, THERAPEUTIC CommonlUsual Name Vaginal Irrigator Predicate Devices La Joie Vaginal Cleaner Container (K000736); Peri-Bottle (K902830) Device Description The irrigating-bottle is hand-squeezed to forc… | 2000 |
| * | K902830 | Peri-BottleSummary page 1…EUTIC CommonlUsual Name Vaginal Irrigator Predicate Devices La Joie Vaginal Cleaner Container (K000736); Peri-Bottle (K902830) Device Description The irrigating-bottle is hand-squeezed to force the cleaning solution… | 1990 |
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 HED devicesHED Douche Apparatus, Vaginal, Therapeutic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HED
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · HED
Too few HED 510(k)s in any year since 2007 to give a median.
Recalls per year · HED
No recall names HED since 2007.
Adverse event reports per year · HED
1in 2010
MAUDE reports naming product code HED, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The WORRRY-REMOVERTMIRRIGATOR is designed for use as a vaginal douche apparatus for general feminine hygiene applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030056: Worry-Remover Irrigator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030056
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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