Company ยท GB
Penlon, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2006. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CAD | Vaporizer, Anesthesia, Non-Heated | 10 |
| BSZ | Gas-Machine, Anesthesia | 4 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 3 |
| CBK | Ventilator, Continuous, Facility Use | 2 |
| CCW | Laryngoscope, Rigid | 2 |
| BSF | Absorber, Carbon-Dioxide | 1 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 |
| DWJ | System, Thermal Regulating | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 2006 | K061102 | PRIMA ANAESTHESIA MACHINE Penlon , Ltd., GB | BSZ |
| May 10, 2006 | K060331 | SIGMA ALPHA VAPORIZER Penlon Limited, GB | CAD |
| Mar 3, 2006 | K053564 | KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 Penlon Limited, GB | CAD |
| Sep 23, 2005 | K051222 | AV-S ANAESTHESIA VENTILATOR Penlon Limited, GB | CBK |
| Aug 9, 2004 | K041076 | DELTA T Penlon , Ltd., GB | CAD |
| Jul 23, 2001 | K010318 | PRIMA OXYGEN MONITOR Penlon , Ltd., GB | CCL |
| Jul 23, 2001 | K010317 | AV 800 VENTILATOR Penlon , Ltd., GB | CBK |
| Jun 8, 2001 | K002343 | SIGMA DELTA Penlon , Ltd., GB | CAD |
| Jul 16, 1996 | K961468 | QUIK-FIL VAPORIZER KEYED FILLER Penlon , Ltd., GB | CAD |
| Apr 2, 1996 | K960944 | PPV VAPORIZER (MODIFICATION) Penlon , Ltd., GB | CAD |
| Oct 6, 1995 | K953179 | CLM LARYNGOSCOPE Penlon , Ltd., GB | CCW |
| Feb 3, 1995 | K942545 | SIGMA ELITE Penlon , Ltd., GB | CAD |
| Nov 4, 1994 | K936046 | SIGMA ELITE Penlon, Inc., GB | CAD |
| Aug 17, 1990 | K902381 | PENLON BREATHING SYSTEM PRESSURE MONITOR Penlon, Inc. | CAP |
| Aug 10, 1989 | K894689 | PENLON IDP PRESSURE FAILURE ALARM Penlon, Inc. | CAP |
| Mar 12, 1985 | K844008 | PENLON AM1000 ANAESTHESIA MACHINE Penlon, Inc., GB | BSZ |
| Mar 12, 1985 | K844007 | PENLON PPV VAPORIZER Penlon, Inc. | CAD |
| Jan 5, 1983 | K823555 | MAGTARAK RESPIRATORY MONITOR & FLOW SENS Penlon, Inc. | BZK |
| Jan 7, 1981 | K803052 | NUFFIELD ANESTHESIA VENTILATOR SER. 400 Penlon, Inc. | BSZ |
| Jan 2, 1981 | K801253 | CREST ELECTRONIC WARMING BLANKET Penlon, Inc. | DWJ |
| Jun 9, 1980 | K801254 | PENLON I.D.P. PRESSSURE FAILURE ALARM Penlon, Inc. | CAP |
| Jun 4, 1980 | K801255 | PENLON JUMBO CARBON DIOXIDE ABSORBER Penlon, Inc. | BSF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2013 | Penlon, Ltd. Delta Vaporizer
An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient. Terminated |
CAD | K002343 |
| Mar 26, 2012 | Penlon, Ltd. 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 maint Terminated |
BSZ | K061102 |
| Mar 18, 2012 | Penlon, Ltd. 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. Terminated |
CCW | None listed |