Product code HEB: 510(k) clearances and predicates
Product code HEB covers Livi Device. FDA lists 189 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
189 clearances on file under product code HEB. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 3 |
| 2023 | 5 |
| 2024 | 2 |
| 2025 | 6 |
| 2026 so far | 1 |
Recent clearances
Newest HEB clearances in the FDA index, with applicant and decision date:
- K252005, Livi Device, applicant Liviwell, Inc., decided 2026-03-20. FDA record
- K253719, Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons, applicant Unibeauty (Hubei) Technology Co., Ltd., decided 2025-12-17. FDA record
- K252939, COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS, applicant Cotton High Tech S.L., decided 2025-10-09. FDA record
- K252613, Unscented menstrual three-piece applicator tampon, applicant Unibeauty (Hubei) Technology Co., Ltd., decided 2025-09-19. FDA record
- K251033, Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons, applicant Unibeauty (Hubei) Technology Co., Ltd., decided 2025-08-13. FDA record
- K242105, SABA Tampons, applicant Essity Higiene Y Salud Mexico. S.A. DE C.V., decided 2025-04-01. FDA record
- K241064, Unscented Tampon, applicant Shandong Intco Hygiene Products Co., Ltd., decided 2025-01-10. FDA record
- K240708, Organic Cotton Tampon; Organic Cotton PESCVcord Tampon, applicant Suzhou Borage Medical Technology Co., Ltd., decided 2024-05-10. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons, COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS. Watch new HEB clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code HEB?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent HEB clearances include Livi Device.
How many 510(k) clearances use product code HEB?
189 at the time this page was generated, from openFDA records.
How do I find a predicate device under HEB?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new HEB clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.