510(k) · Cleared
ClearedOrganic Cotton Tampon; Organic Cotton PESCVcord Tampon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Borage Medical Technology Co., Ltd. · HEB Tampon, Menstrual, Unscented
Cleared on May 10, 2024 as substantially equivalent to K222046 (Suzhou Borage Medical Technology Co., Ltd., 2022) after a 56-day review. Its family tree reaches back 1 generation to 2022.
- Decided
- May 10, 2024
- Review
- 56 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K222046 (2022). No later device cites it as a predicate yet.
- Root · 1 generation backK222046 Unscented Menstrual TamponSuzhou Borage Medical Technology Co., Ltd. · 2022
- This deviceK240708 Organic Cotton Tampon; Organic Cotton PESCVcord TamponSuzhou Borage Medical Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K222046 | Unscented Menstrual Tampon | Suzhou Borage Medical Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord Tampon | Suzhou Borage Medical Technology Co., Ltd. | 2024 | — |
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 HEB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HEB device
- #1 K251033 Unscented menstrual long applicator tampon…score 14.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K222046 | Unscented Menstrual TamponSummary page 5…Regulation No. 21 CFR 884.5470 3. Legally Marketed Predicate Device Trade Name Unscented Menstrual Tampon 510(k) Number K222046 Product Code HEB Manufacturer Suzhou Borage Medical Technology Co., Ltd. The predicate device… | 2022 |
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?
- Its one ancestor has no recall.
How does its category compare?
All HEB devicesHEB Tampon, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · HEB
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HEB
82in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HEB
29in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HEB
452in 2025
MAUDE reports naming product code HEB, 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 | 38 |
| 2008 | 1 | — | 0 | 31 |
| 2009 | 7 | 136 | 0 | 30 |
| 2010 | 3 | 76 | 1 | 138 |
| 2011 | 3 | 28 | 1 | 291 |
| 2012 | 3 | 114 | 0 | 416 |
| 2013 | 2 | — | 0 | 259 |
| 2014 | 4 | 173 | 0 | 167 |
| 2015 | 5 | 114 | 0 | 132 |
| 2016 | 1 | — | 0 | 101 |
| 2017 | 2 | — | 0 | 194 |
| 2018 | 5 | 140 | 4 | 363 |
| 2019 | 7 | 182 | 0 | 3,034 |
| 2020 | 2 | — | 0 | 1,714 |
| 2021 | 6 | 60 | 0 | 1,403 |
| 2022 | 3 | 81 | 0 | 1,055 |
| 2023 | 5 | 109 | 0 | 702 |
| 2024 | 2 | — | 0 | 534 |
| 2025 | 6 | 82 | 29 | 452 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240708: Organic Cotton Tampon; Organic Cotton PESCVcord Tampon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240708
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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