Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HEB — Predicate Candidate Screening
189 FDA 510(k) clearances under this product code; the 50 most recent screened below.
81 daysmedian FDA review time
267 days90th percentile
189clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252005 | Livi Device | Liviwell, Inc. | 2026-03-20 | 266 | 0 |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstr | Unibeauty (Hubei) Technology Co., Ltd. | 2025-12-17 | 23 | 0 |
| K252939 | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | Cotton High Tech S.L. | 2025-10-09 | 24 | 0 |
| K252613 | Unscented menstrual three-piece applicator tampon | Unibeauty (Hubei) Technology Co., Ltd. | 2025-09-19 | 31 | 0 |
| K251033 | Unscented menstrual long applicator tampon; Unscented menstr | Unibeauty (Hubei) Technology Co., Ltd. | 2025-08-13 | 132 | 0 |
| K242105 | SABA Tampons | Essity Higiene Y Salud Mexico. S.A. DE C.V. | 2025-04-01 | 257 | 0 |
| K241064 | Unscented Tampon | Shandong Intco Hygiene Products Co., Ltd. | 2025-01-10 | 267 | 0 |
| K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord Tampon | Suzhou Borage Medical Technology Co., Ltd. | 2024-05-10 | 56 | 0 |
| K232060 | TOSAMA Reusable Applicator | Tosama, D.O.O. | 2024-04-12 | 276 | 0 |
| K232598 | Unscented Menstrual Tampon | Unibeauty (Hubei) Technology Co., Ltd. | 2023-12-15 | 109 | 0 |
| K223883 | Daye Tampon | Annes Daye, Ltd. | 2023-08-18 | 234 | 0 |
| K231341 | Organic cotton tampon, Viscose tampon | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | 2023-08-14 | 97 | 0 |
| K230419 | Sequel Tampon with Plastic Applicator | Tampro, Inc. | 2023-08-03 | 168 | 0 |
| K223749 | U by Kotex® Click® Unscented Menstrual Tampons | Kimberly-Clark Corporation | 2023-01-06 | 23 | 0 |
| K222046 | Unscented Menstrual Tampon | Suzhou Borage Medical Technology Co., Ltd. | 2022-09-30 | 81 | 0 |
| K212277 | Tempo Tampon | Dong-A Pharmaceutical Co., Ltd. | 2022-04-21 | 275 | 0 |
| K220238 | Cohitech Cottonlock Tampons with Reusable Applicator | Cotton High Tech S.L. | 2022-02-25 | 28 | 0 |
| K211775 | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons | Cotton High Tech S.L. | 2021-10-22 | 135 | 0 |
| K212479 | Cohitech Reusable Tampon Applicator | Cotton High Tech S.L. | 2021-10-08 | 60 | 0 |
| K212272 | Tempo Natural Tampon | Dong-A Pharmaceutical Co., Ltd. | 2021-09-17 | 59 | 0 |
| K212304 | Callaly Tampliner (super plus absorbency) | Calla Lily Personal Care, Ltd. | 2021-08-19 | 27 | 0 |
| K211519 | Every Cycle Reusable Tampon Applicator | Cycle, LLC | 2021-08-13 | 88 | 0 |
| K211469 | Callaly Tampliner | Calla Lily Personal Care, Ltd. | 2021-06-10 | 30 | 0 |
| K201003 | Callaly Tampliner | Calla Lily Personal Care, Ltd. | 2020-12-07 | 235 | 0 |
| K192557 | Youjia Unscented Tampon with Plastic Applicators | Qingdao Youjia Hygiene Technology Co., Ltd. | 2020-02-13 | 149 | 0 |
| K191666 | Unscented W long plastic and cardboard applicator tampons | Ontex Bvba | 2019-12-20 | 182 | 0 |
| K191431 | Interlude Rolled Tampons in Plastic Applicator | Albaad Fem | 2019-10-07 | 131 | 0 |
| K182142 | FEMME Applicator Tampon | Jiangsu Yoai Technology Co., Ltd. | 2019-08-28 | 386 | 0 |
| K182817 | CottonDay Tampon | Taebong Co., Ltd. | 2019-07-22 | 292 | 0 |
| K182814 | Rael Tampon | Rael, Inc. | 2019-07-15 | 285 | 0 |
| K190218 | Unscented Menstrual Tampon | Qingdao Youjia Hygiene Technology Co., Ltd. | 2019-05-09 | 94 | 0 |
| K182813 | COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT | Cotton High Tech S.L. | 2019-03-15 | 163 | 0 |
| K181911 | Interlude 100% Cotton Tampon | Albaad Fem | 2018-11-02 | 108 | 0 |
| K180850 | re.t.a Reuseable Tampon Applicator | Thinx, Inc. | 2018-08-20 | 140 | 0 |
| K173225 | Interlude and private label Unscented 3-piece compact applic | Albaad Fem | 2018-06-15 | 255 | 0 |
| K180167 | Playtex Stella Tampons | Playtex Manufacturing, Inc. | 2018-05-30 | 128 | 0 |
| K172504 | Tosama Biobased Applicator Tube Menstrual Tampon | Tosama, D.O.O. | 2018-02-09 | 175 | 0 |
| K172118 | U by Kotex Click Unscented Menstrual Tampons | Kimberly-Clark Corporation | 2017-10-11 | 90 | 0 |
| K162746 | Ontex and other proprietary names | Ontex Bvba | 2017-03-03 | 154 | 0 |
| K161877 | Opal by Femtex Pull & Snap and Private Label Unscented Compa | First Quality Hygienic, Inc. | 2016-08-05 | 28 | 0 |
| K152284 | COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMP | Cotton High Tech S.L. | 2015-12-04 | 114 | 0 |
| K151470 | Opal by Femtex and Private Label Unscented Compact Applicato | First Quality Hygienic, Inc. | 2015-11-02 | 154 | 0 |
| K151170 | Tosama 100% Organic Cotton Menstrual Tampon | Tosama, D.O.O. | 2015-07-02 | 62 | 0 |
| K142786 | Ontex Unscented Tampons with Colored Plastic Applicators | Ontex Bvba | 2015-06-23 | 270 | 0 |
| K150897 | Tosama 100% Cotton Menstrual Tampon | Tosama, D.O.O. | 2015-04-20 | 18 | 0 |
| K140077 | ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED | Albaad , Ltd. | 2014-09-22 | 252 | 0 |
| K141294 | U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS | Kimberly-Clark Corp. | 2014-08-25 | 98 | 0 |
| K132595 | ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED | Ontex Bvba | 2014-04-23 | 247 | 0 |
| K133244 | TAMPAX M PLASTIC TAMPONS, UNSCENTED | The Procter & Gamble Company | 2014-01-09 | 79 | 0 |
| K131543 | TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED | Procter & Gamble Co. | 2013-06-20 | 22 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda