Data / Medical devices / United Kingdom / Penlon Ltd.
Penlon Ltd.: FDA-registered device maker in ABINGDON Oxfordshire, United Kingdom, 5 510(k) clearances
Penlon Ltd. is registered with the FDA (registration 9610531) in ABINGDON Oxfordshire, United Kingdom. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 28, 2006. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9610531
- FEI number
- 3002807907
- Address
- Abingdon Science Park Barton Lane, ABINGDON Oxfordshire, United Kingdom, OX14 3NB
- Owner or operator
- PENLON LTD. (9029886)
- Roles
- Manufacturer
- First device listed
- April 24, 2002
- Registered through
- 2026
- Brand names listed
- AV-S Anaesthesia Combined Ventilator, AV-S Anaesthesia Remote Ventilator, AV-S Anaesthesia Ventilator, AV-S MRI Anaesthesia Ventilator, Keyed Filler Bottle Adaptor Halothane, Keyed Filler Bottle Adaptor Isoflurane, Keyed Filler Bottle Adaptor Sevoflurane, Oxygen Therapy Flowmeters and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Manufacturer | accessdata.fda.gov |
| Gas-Machine, Anesthesia | BSZ | 2 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Thorpe, Uncompensated | BYM | 1 | Manufacturer | accessdata.fda.gov |
| Vaporizer, Anesthesia, Non-Heated | CAD | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 28, 2006 | K061102 | PRIMA ANAESTHESIA MACHINE | BSZ | Substantially Equivalent | Penlon , Ltd. | accessdata.fda.gov |
| March 3, 2006 | K053564 | KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 | CAD | Substantially Equivalent | Penlon Limited | accessdata.fda.gov |
| September 23, 2005 | K051222 | AV-S ANAESTHESIA VENTILATOR | CBK | Substantially Equivalent | Penlon Limited | accessdata.fda.gov |
| June 8, 2001 | K002343 | SIGMA DELTA | CAD | Substantially Equivalent | Penlon , Ltd. | accessdata.fda.gov |
| July 16, 1996 | K961468 | QUIK-FIL VAPORIZER KEYED FILLER | CAD | Substantially Equivalent | Penlon , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 14, 2013 | 65286 | Class II | Terminated | Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient. | 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 daily Pre-Use Check sections of the User Manual to ensure that the instructions are explicit and clear. | accessdata.fda.gov |
| November 29, 2011 | 60647 | Not yet classified | Terminated | Anesthesia Machines (digital display assembly); A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventil | Penlon, Ltd has identified the potential for the premature failure of a component in some Electronic Flowmeter sensor display unit PCB assemblies. | accessdata.fda.gov |
| September 21, 2011 | 59992 | Not yet classified | Terminated | Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and Mac 3 (part numbers 50675, 50675/F, 50675/BMI) Product Usage: Disposable laryngoscope blades. | Disposable laryngoscope blades incorrectly labeled with wrong size. | accessdata.fda.gov |
| March 10, 2011 | 58820 | Not yet classified | Terminated | Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647 Disposable laryngoscope blades | Disposable laryngoscope blades incorrectly labeled with wrong size. | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Thorpe, Uncompensated
- All makers of Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- All makers of Vaporizer, Anesthesia, Non-Heated
- All makers of Laryngoscope, Rigid
- All makers of Gas-Machine, Anesthesia
- All makers of Ventilator, Continuous, Facility Use
Updated July 2, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.