Tanita Corp. of America: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Tanita Corp. of America” (first 1993, latest 2004), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 196 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| MNW | Analyzer, Body Composition | 4 | 4 |
| DSB | Plethysmograph, Impedance | 1 | 1 |
| FRW | Scale, Patient | 1 | 1 |
Review panels
Most recent Tanita Corp. of America 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040778 | TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9) | MNW | 2004-12-23 | 272 |
| K040978 | TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE | MNW | 2004-07-22 | 98 |
| K033157 | TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418 | MNW | 2004-04-08 | 191 |
| K014009 | TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE | MNW | 2002-06-24 | 201 |
| K930599 | BODY FAT ANALYZER MODEL TBF-105 | DSB | 1994-11-01 | 634 |
| K932572 | DIGITAL BABY SCALE MODEL BLB-12 | FRW | 1993-11-16 | 173 |
Recalls
openFDA lists no recalls under a recalling firm named Tanita Corp. of America.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tanita Corporation of America (2 510(k)s)
- Tanita Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tanita Corp. of America?
FDA lists 6 510(k) clearances under the applicant name “Tanita Corp. of America” (first 1993, latest 2004), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tanita Corp. of America?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tanita Corp. of America is 196 days.
Which FDA product codes appear under Tanita Corp. of America?
The most frequent FDA product codes under this applicant name are MNW (Analyzer, Body Composition, 4); DSB (Plethysmograph, Impedance, 1); FRW (Scale, Patient, 1).
Next steps
- See all 6 Tanita Corp. of America clearances with predicates and recalls
- Run predicate analysis for product code MNW, Tanita Corp. of America's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.