Penlon
Anaesthetic vaporizer / Enflurane, use in the MRI environment.
1manufacturer
11catalogue numbers in this listing
9510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Record
| Listed by | Penlon Ltd., United Kingdom |
|---|---|
| FDA product code | CAD |
| Device type | Vaporizer, Anesthesia, Non-Heated |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5880 |
| Establishment | Manufacturer |
| 510(k) | K002343 |
| Record published | 2024-12-06 |
| Record revised | 2024-12-06 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2024-12-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Sigma Delta Vaporizer / Sevoflurane | In distribution | |
| 53450 | In distribution | |
| Sigma Delta MRI Vaporizer / Sevoflurane | In distribution | |
| 53453 | In distribution | |
| 53454 | In distribution | |
| Sigma Delta Vaporizer / Isoflurane | In distribution | |
| Sigma Delta MRI Vaporizer / Isoflurane | In distribution | |
| 54909 | In distribution | |
| Sigma Delta Vaporizer / Halothane | In distribution | |
| Sigma Delta MRI | Withdrawn | |
| Sigma Delta | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 107 |
| TEC 7 | Datex-Ohmeda, Inc. | 10 |
| Antispil | Southmedic, Inc. | 5 |
| Vapofil™ | Southmedic, Inc. | 5 |
| TEC | Datex-Ohmeda, Inc. | 4 |
| TEC 6 Plus | Datex-Ohmeda, Inc. | 3 |
| AincA® | Anesthesia Associates, Inc. | 1 |
| Flexible arm assembly FRU | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| V80 Anesthetic Vaporizer | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Sevoflurane Key Filler Vaporizer(FDA) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Key Filler Bottle Adaptor MRI | Penlon Ltd. | 1 |
| Vapor 3000 | Drägerwerk AG & Co. KGaA | 1 |
Showing 12 of 20. All products under Vaporizer, Anesthesia, Non-Heated
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060331 | 2006-05-10 |
| K053564 | 2006-03-03 |
| K041076 | 2004-08-09 |
| K002343 | 2001-06-08 |
| K961468 | 1996-07-16 |
| K960944 | 1996-04-02 |
| K942545 | 1995-02-03 |
| K936046 | 1994-11-04 |
| K844007 | 1985-03-12 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Penlon Ltd. | 510(k) number | 2013-05-14 | Class II | Nonconforming Material/Component | It has come to Penlon Ltd’s attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to the clinical use of the vaporizer. Penlon Ltd has updated the Installation and dai | 9208 (of which 576 were within the US) | 2014-05-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.