510(k) · Cleared
ClearedCohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator Organic Cotton Tampons
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cotton High Tech S.L. · HEB Tampon, Menstrual, Unscented
Cleared on Dec 4, 2015 as substantially equivalent to K991118 (Personal Products Co., 1999) and 1 other predicate after a 114-day review. Its family tree reaches back 3 generations to 2004. 3 later devices descend from it.
- Decided
- Dec 4, 2015
- Review
- 114 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K040999 (2004). 5 ancestors in all, the oldest K954942 (1996). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK040999 Tampax Tampons (Junior, Regular, Super and Super Plus Absorbencies)Procter & Gamble Co. · 2004
- 2 generations backK061486 Tampax Tampons - (Light,Regular,Super and Super Plus Absorbencies)Procter & Gamble Co. · 2006
- 1 generation backK091084 Maxim Menstrual Tampons & Organyc Menstrual TamponsCotton High Tech S.L. · 2009
- This deviceK152284 Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact…Cotton High Tech S.L. · 2015
- Descendant · cites it directly · 2 of its ownK211775 Cohitech Organic Cotton Non-Applicator Cottonlock TamponsCotton High Tech S.L. · 2021
- Descendant · 2 generations on · 0 of its ownK252939 Cohitech Organic Cotton Compact Applicator TamponsCotton High Tech S.L. · 2025
- Descendant · 2 generations on · 0 of its ownK220238 Cohitech Cottonlock Tampons with Reusable ApplicatorCotton High Tech S.L. · 2022
Most influential descendants
Showing 3 of 3 · See all- K211775Cohitech Organic Cotton Non-Applicator Cottonlock TamponsCotton High Tech S.L. · 2021 · cites it directly2descendants
- K252939Cohitech Organic Cotton Compact Applicator TamponsCotton High Tech S.L. · 2025 · 2 generations on0descendants
- K220238Cohitech Cottonlock Tampons with Reusable ApplicatorCotton High Tech S.L. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040999 | Tampax Tampons (Junior, Regular, Super and Super Plus Absorbencies) | Procter & Gamble Co. | 2004 | — |
| −2 | K061486 | Tampax Tampons - (Light,Regular,Super and Super Plus Absorbencies) | Procter & Gamble Co. | 2006 | — |
| −1 | K091084 | Maxim Menstrual Tampons & Organyc Menstrual Tampons | Cotton High Tech S.L. | 2009 | — |
| 0 (this device) | K152284 | Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator… | Cotton High Tech S.L. | 2015 | — |
| +1 | K211775 | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons | Cotton High Tech S.L. | 2021 | — |
| +2 | K252939 | Cohitech Organic Cotton Compact Applicator Tampons | Cotton High Tech S.L. | 2025 | — |
| +2 | K220238 | Cohitech Cottonlock Tampons with Reusable Applicator | Cotton High Tech S.L. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K991118 | O.B. Applicator Tampons, O.B. TamponsSummary page 4…eted Equivalent Device Company Product 510(k)# Personal Products Company O.b. non applicator tampons K991118 Cotton High Tech S.L. Cotton menstrual tampons K091084 DEVICE DESCRIPTION: The devices are conventional u… | 1999 |
| * | K091084 | Maxim Menstrual Tampons & Organyc Menstrual TamponsSummary page 4…510(k)# Personal Products Company O.b. non applicator tampons K991118 Cotton High Tech S.L. Cotton menstrual tampons K091084 DEVICE DESCRIPTION: The devices are conventional unscented menstrual tampons consisting of an absorbent pledget, with or withou… | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211775 | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons | 2021 | 2 |
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K211775 (Cotton High Tech S.L., 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HEB devicesHEB Tampon, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Cohitech Non Applicator Organic Cotton Tampons and Cohitech Compact Applicator Organic Cotton Tampons (regular, super and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.
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/K152284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152284: Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator Organic Cotton Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152284
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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