510(k) · Cleared
ClearedO.B. Applicator Tampons, O.B. Tampons
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Personal Products Co. · HEB Tampon, Menstrual, Unscented
Cleared on Jun 29, 1999 after an 89-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jun 29, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK991118 O.B. Applicator Tampons, O.B. TamponsPersonal Products Co. · 1999
- Descendant · cites it directly · 3 of its ownK152284 Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact…Cotton High Tech S.L. · 2015
- Descendant · 2 generations on · 2 of its ownK211775 Cohitech Organic Cotton Non-Applicator Cottonlock TamponsCotton High Tech S.L. · 2021
- Descendant · 3 generations on · 0 of its ownK252939 Cohitech Organic Cotton Compact Applicator TamponsCotton High Tech S.L. · 2025
- Descendant · 3 generations on · 0 of its ownK220238 Cohitech Cottonlock Tampons with Reusable ApplicatorCotton High Tech S.L. · 2022
Most influential descendants
Showing 4 of 4 · See all- K152284Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator Organic…Cotton High Tech S.L. · 2015 · cites it directly3descendants
- K211775Cohitech Organic Cotton Non-Applicator Cottonlock TamponsCotton High Tech S.L. · 2021 · 2 generations on2descendants
- K252939Cohitech Organic Cotton Compact Applicator TamponsCotton High Tech S.L. · 2025 · 3 generations on0descendants
- K220238Cohitech Cottonlock Tampons with Reusable ApplicatorCotton High Tech S.L. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991118 | O.B. Applicator Tampons, O.B. Tampons | Personal Products Co. | 1999 | — |
| +1 | K152284 | Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator… | Cotton High Tech S.L. | 2015 | — |
| +2 | K211775 | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons | Cotton High Tech S.L. | 2021 | — |
| +3 | K252939 | Cohitech Organic Cotton Compact Applicator Tampons | Cotton High Tech S.L. | 2025 | — |
| +3 | K220238 | Cohitech Cottonlock Tampons with Reusable Applicator | Cotton High Tech S.L. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | o.b.® non-applicator Tampons Named without a submission number | |
| * | — | o.b.® applicator Tampons Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152284 | Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator Organic… | 2015 | 3 |
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, K152284 (Cotton High Tech S.L., 2015) has gone furthest, with 3 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.
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?
o.b.® Tampons are used to absorb menstrual fluid or other vaginal discharge.
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/K991118 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991118: O.B. Applicator Tampons, O.B. Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991118
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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