Blease Medical Equipment , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Blease Medical Equipment , Ltd.” (first 1999, latest 2004), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 218 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 |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | 4 | 4 |
| CBK | Ventilator, Continuous, Facility Use | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Blease Medical Equipment , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041430 | BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 | BSZ | 2004-10-07 | 132 |
| K003251 | BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 | BSZ | 2001-05-23 | 218 |
| K001727 | MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES | BSZ | 2000-08-09 | 64 |
| K982132 | BLEASE 6200 ANAESTHESIA VENTILATOR | CBK | 1999-04-15 | 302 |
| K982137 | BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE | BSZ | 1999-04-09 | 296 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-03-26.
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.
- Blease USA, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Blease Medical Equipment , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Blease Medical Equipment , Ltd.” (first 1999, latest 2004), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Blease Medical Equipment , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Blease Medical Equipment , Ltd. is 218 days.
Which FDA product codes appear under Blease Medical Equipment , Ltd.?
The most frequent FDA product codes under this applicant name are BSZ (Gas-Machine, Anesthesia, 4); CBK (Ventilator, Continuous, Facility Use, 1).
Next steps
- See all 5 Blease Medical Equipment , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BSZ, Blease Medical Equipment , 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.