Biospace Corporation Limited: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Biospace Corporation Limited” (first 2005, latest 2014), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 144 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 | 3 | 144 |
| 2014 | 1 | 110 |
| 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 | 8 | 8 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
Review panels
Most recent Biospace Corporation Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141483 | BIOSPACE BODY COMPOSITION ANALYZER | MNW | 2014-09-23 | 110 |
| K130777 | INBODY | MNW | 2013-11-25 | 249 |
| K131064 | BIOSPACE | DXN | 2013-09-04 | 141 |
| K123228 | INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) | MNW | 2013-03-08 | 144 |
| K110689 | INBODY | MNW | 2011-08-19 | 157 |
| K092786 | INBODY, MODELS: 270, R20, R20B | MNW | 2010-03-10 | 181 |
| K062603 | BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230 | MNW | 2007-02-15 | 167 |
| K052646 | BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 | MNW | 2005-12-16 | 81 |
| K042528 | INBODY, MODEL 3.0 | MNW | 2005-01-11 | 116 |
Recalls
openFDA lists no recalls under a recalling firm named Biospace Corporation Limited.
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.
- Biospace Med (4 510(k)s)
- Biospace Co.,Ltd (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biospace Corporation Limited?
FDA lists 9 510(k) clearances under the applicant name “Biospace Corporation Limited” (first 2005, latest 2014), 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 Biospace Corporation Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biospace Corporation Limited is 144 days.
Which FDA product codes appear under Biospace Corporation Limited?
The most frequent FDA product codes under this applicant name are MNW (Analyzer, Body Composition, 8); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1).
Next steps
- See all 9 Biospace Corporation Limited clearances with predicates and recalls
- Run predicate analysis for product code MNW, Biospace Corporation Limited'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.