Tambrands, Inc.: FDA clearances and approvals
Tambrands, Inc. has 70 FDA 510(k) clearances (first 1984, latest 1996), across 6 product codes in 2 review panels. Median 510(k) review time: 48 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | 34 | 34 |
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | 13 | 13 |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | 11 | 11 |
| HHD | Pad, Menstrual, Unscented | 10 | 10 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
Review panels
Most recent Tambrands, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962476 | UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR | HEB | 1996-08-13 | 49 |
| K960341 | TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS | HEB | 1996-04-17 | 84 |
| K952344 | SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS | HIL | 1995-07-28 | 70 |
| K944834 | UNSCENTED MENSTRUAL TAMPONS | HEB | 1994-12-21 | 82 |
| K924303 | TAMPAX TAMPON, REGULAR ABSORBENCY | HEB | 1993-07-29 | 358 |
| K923932 | TAMPAX TAMPONS, SUPER ABSORBENCY | HEB | 1993-07-29 | 358 |
| K896989 | TAMPAX TAMPON | HEB | 1989-12-22 | 10 |
| K896115 | TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER | HIL | 1989-12-13 | 51 |
| K896114 | TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB. | HEB | 1989-12-13 | 51 |
| K896113 | TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS | HEB | 1989-12-13 | 51 |
60 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tambrands, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Tambrands, Inc. have?
Tambrands, Inc. has 70 FDA 510(k) clearances (first 1984, latest 1996), across 6 product codes in 2 review panels.
How long does FDA take to clear Tambrands, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tambrands, Inc.'s cleared 510(k)s is 48 days.
What devices does Tambrands, Inc. make?
Its most frequent FDA product codes are HEB (Tampon, Menstrual, Unscented, 34); HIL (Tampon, Menstrual, Scented, Scented-Deodorized, 13); HHL (Pad, Menstrual, Scented, Scented-Deodorized, 11).
Has Tambrands, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tambrands, Inc. Related entities may recall under other names.
Next steps
- See all 70 Tambrands, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HEB, Tambrands, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.