Blease Medical Equipment, Ltd.
Appollo Beach, FL, US
Blease Medical Equipment , Ltd. appears in FDA device records in Appollo Beach, FL. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Blease Medical Equipment, Ltd. between 1999 and 2004. The busiest year on record is 1999, with 2. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K041430 | BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 | BSZ | Substantially Equivalent | |
| K003251 | BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 | BSZ | Substantially Equivalent | |
| K001727 | MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES | BSZ | Substantially Equivalent | |
| K982132 | BLEASE 6200 ANAESTHESIA VENTILATOR | CBK | Substantially Equivalent | |
| K982137 | BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE | BSZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1408-2010 | The BleaseSirius and BleaseFocus Anaesthesia Systems. | Potential for delivery of a lower than set concentration of anaesthetic to a patient due to a sticking valve. The lower shuttle may become jammed, not permitting flow of anaesthesia gas through the vapouriser. The vapouriser back bar mounting valves will require exchange only on the systems identified in this matter, no other systems are affected. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain