Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tampax, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
88 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832972 | REGULAR DEODORANT MAXITHINS PADS | Tampax, Inc. | 1983-11-28 | 88 | 0 |
| K832971 | DEODORANT MAXITHINS PANTY SHIELD | Tampax, Inc. | 1983-11-28 | 88 | 0 |
| K832973 | TAMPAX SUPER DEODORANT MAXITHINS | Tampax, Inc. | 1983-11-28 | 88 | 0 |
| K832974 | MAXITHINS UNSCENTED PANTY SHIELDS | Tampax, Inc. | 1983-10-14 | 43 | 0 |
| K821800 | REGULAR MAXITHINS PADS & SUPER MAXITHINS | Tampax, Inc. | 1982-06-25 | 18 | 0 |
| K820174 | TAMPAX TAMPONS | Tampax, Inc. | 1982-03-18 | 56 | 0 |
| K813642 | PETAL SOFT PLASTIC APPLICATOR TAMPAX | Tampax, Inc. | 1982-01-25 | 26 | 0 |
| K810143 | TAMPAX DEODORANT TAMPONS | Tampax, Inc. | 1981-03-04 | 42 | 0 |
| K810160 | TAMPAX MAXITHINS PADS | Tampax, Inc. | 1981-01-28 | 6 | 0 |
| K802760 | PETAL SOFT PLASTIC APPLICATOR TAMPAX | Tampax, Inc. | 1981-01-12 | 68 | 0 |
| K800777 | TAMPAX TAMPONS | Tampax, Inc. | 1980-05-14 | 36 | 0 |
| K780648 | MODIFIED UNTREATED TAMPAX TAMPONS | Tampax, Inc. | 1978-05-31 | 44 | 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