Bodystat , Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Bodystat , Ltd.” (first 1995, latest 2011), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 234 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 | 7 | 7 |
| DSB | Plethysmograph, Impedance | 1 | 1 |
Review panels
Most recent Bodystat , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082255 | QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT | MNW | 2011-02-07 | 913 |
| K082254 | MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT | MNW | 2011-02-07 | 913 |
| K082253 | BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT | MNW | 2008-11-25 | 109 |
| K002835 | BODYSTAT | MNW | 2001-07-03 | 294 |
| K994242 | BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT | MNW | 2000-03-15 | 90 |
| K980971 | BODYSTAT DUALSCAN 2005 | MNW | 1998-06-11 | 87 |
| K971554 | BODYSTAT | MNW | 1997-11-26 | 210 |
| K951097 | BODYSTAY | DSB | 1995-11-22 | 259 |
Recalls
openFDA lists no recalls under a recalling firm named Bodystat , Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bodystat , Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Bodystat , Ltd.” (first 1995, latest 2011), across 2 product codes in 2 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 Bodystat , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bodystat , Ltd. is 234 days.
Which FDA product codes appear under Bodystat , Ltd.?
The most frequent FDA product codes under this applicant name are MNW (Analyzer, Body Composition, 7); DSB (Plethysmograph, Impedance, 1).
Next steps
- See all 8 Bodystat , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MNW, Bodystat , Ltd.'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.