FDA product code · Obstetrics/Gynecology
HEBTampon, Menstrual, Unscented
Product code HEB covers Tampon, Menstrual, Unscented, a Class II device regulated under 21 CFR 884.5470. FDA has cleared 189 devices in this code, 5 of them in the last 12 months. Median review time across the 189 most recent decisions is 81 days. openFDA lists 36 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 884.5470
- Review panel
- Obstetrics/Gynecology
- Clearances
- 189
What is happening in HEB right now?
HEB (Tampon, Menstrual, Unscented) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-1182-2026). 1 first-time filer in the last 12 months, Liviwell, Inc (K252005). The code is crowded, scoring 66 of 100 — 58 companies hold a clearance here and 5 arrived in the last 12 months (HEB:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1182-2026 |
| New entrant | Worth knowing | K252005 |
| Crowding | Context | HEB:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code HEB cover?
HEB is FDA's product code for Tampon, Menstrual, Unscented, a Class II device regulated under 21 CFR 884.5470.
An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.
Source: openFDA device/classification · record HEB · retrieved
How many devices has FDA cleared in HEB?
FDA has cleared 189 devices under product code HEB since the 510(k) programme began in 1976, 5 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252005 | Livi Device | Liviwell, Inc. | |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. | |
| K252939 | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | Cotton High Tech S.L. | |
| K252613 | Unscented menstrual three-piece applicator tampon | Unibeauty (Hubei) Technology Co., Ltd. | |
| K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. | |
| K242105 | SABA Tampons | Essity Higiene Y Salud Mexico. S.A. DE C.V. | |
| K241064 | Unscented Tampon | Shandong Intco Hygiene Products Co., Ltd. | |
| K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord Tampon | Suzhou Borage Medical Technology Co., Ltd. | |
| K232060 | TOSAMA Reusable Applicator | Tosama, D.O.O. | |
| K232598 | Unscented Menstrual Tampon | Unibeauty (Hubei) Technology Co., Ltd. |
How long does FDA review take for HEB?
The median FDA review time for HEB is 81 days, measured across the 189 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in HEB?
openFDA lists 36 recall records against product code HEB. A recall record covers one firm's corrective action and may span many device lots.
Z-1182-2026Open, ClassifiedGOLD STAR DISTRIBUTION INC
Potential exposure of rodents and rodent activity in the distribution center.
Z-0379-2026Open, ClassifiedDAYE (ANNE'S DAY LTD)
Product lacks 510(k) clearance.
Z-0380-2026Open, ClassifiedDAYE (ANNE'S DAY LTD)
Product lacks 510(k) clearance.
Z-0381-2026Open, ClassifiedDAYE (ANNE'S DAY LTD)
Product lacks 510(k) clearance.
Z-0382-2026Open, ClassifiedDAYE (ANNE'S DAY LTD)
Product lacks 510(k) clearance.
Showing the 5 most recently initiated of 36. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for HEB?
MAUDE holds 1,650 adverse-event reports naming product code HEB, 300 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in HEB unusual?
One month sits above HEB's own expected range: 1 May 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 52 | Insufficient history | No expected range — too little history | |
| 56 | Insufficient history | No expected range — too little history | |
| 82 | Insufficient history | No expected range — too little history | |
| 55 | Insufficient history | No expected range — too little history | |
| 60 | Insufficient history | No expected range — too little history | |
| 60 | Insufficient history | No expected range — too little history | |
| 69 | Insufficient history | No expected range — too little history | |
| 42 | Insufficient history | No expected range — too little history | |
| 66 | Insufficient history | No expected range — too little history | |
| 35 | Insufficient history | No expected range — too little history | |
| 57 | Insufficient history | No expected range — too little history | |
| 45 | Insufficient history | No expected range — too little history | |
| 52 | Insufficient history | No expected range — too little history | |
| 44 | Insufficient history | No expected range — too little history | |
| 50 | Insufficient history | No expected range — too little history | |
| 50 | Insufficient history | No expected range — too little history | |
| 45 | Insufficient history | No expected range — too little history | |
| 32 | Insufficient history | No expected range — too little history | |
| 47 | Insufficient history | No expected range — too little history | |
| 39 | Insufficient history | No expected range — too little history | |
| 38 | Insufficient history | No expected range — too little history | |
| 43 | 21–54 | Within expected (21–54) | |
| 23 | 20–48 | Within expected (20–48) | |
| 24 | 19–50 | Within expected (19–50) | |
| 35 | 14–51 | Within expected (14–51) | |
| 47 | 16–46 | Above expected (16–46) | |
| 37 | 20–54 | Within expected (20–54) | |
| 35 | 36–81 | Below expected (36–81) | |
| 40 | 20–57 | Within expected (20–57) | |
| 45 | 22–60 | Within expected (22–60) | |
| 43 | 23–61 | Within expected (23–61) | |
| 38 | 22–55 | Within expected (22–55) | |
| 31 | 24–60 | Within expected (24–60) | |
| 30 | 23–67 | Within expected (23–67) | |
| 37 | 15–53 | Within expected (15–53) | |
| 47 | 18–59 | Within expected (18–59) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in HEB.
Who has entered HEB in the last year?
One company filed in HEB for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Liviwell, Inc. | K252005 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in HEB?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in HEB?
Across the 189 most recent decisions, these applicants filed most often in HEB.
| Applicant | Recent clearances |
|---|---|
| Tambrands, Inc. | 34 |
| Personal Products Co. | 14 |
| Kimberly-Clark Corp. | 12 |
| First Quality Hygienic, Inc. | 8 |
| Cotton High Tech S.L. | 7 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in HEB files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Kimberly-Clark Corporation | 16 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch HEB
Get an email the morning anything changes in HEB — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Obstetrics/Gynecology
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.