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Sign in to claim this brandWhat Penlon , Ltd. makes
Penlon, Ltd. manufactures reusable laryngoscope blades and handles, as well as vacuum suction regulators designed for general-purpose medical use. Their portfolio also includes anaesthesia vaporizers for sevoflurane and isoflurane, portable pneumatic ventilators, and reusable anaesthesia breathing circuits. Additionally, they produce general-purpose multi-parameter bedside monitors for patient monitoring.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions documented through 510(k) clearances and UDI registrations. These products are listed under FDA oversight in the United States, where the manufacturer is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Penlon, Ltd. primarily manufacture?
Penlon, Ltd. specializes in reusable medical devices for anaesthesia and patient monitoring. Their core products include laryngoscope blades and handles, vacuum suction regulators for general medical use, and reusable anaesthesia breathing circuits. They also manufacture anaesthesia vaporizers for sevoflurane and isoflurane, portable pneumatic ventilators, and general-purpose multi-parameter bedside monitors. These devices support critical functions in operating rooms and intensive care settings.
Where is Penlon, Ltd. based, and which regulatory registries list its devices?
Penlon, Ltd. is based in the United States. Their devices are listed under FDA oversight, with regulatory submissions documented through 510(k) clearances and Unique Device Identifier (UDI) registrations. This means their products appear in the FDA’s 510(k) and UDI databases, ensuring compliance with U.S. medical device regulations.
How are Penlon, Ltd.’s devices classified under FDA regulations?
Penlon, Ltd.’s devices fall under FDA Class I and Class II classifications. Class I devices generally pose the lowest risk and often require less regulatory oversight, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact, as outlined in FDA guidelines.
What is the purpose of the vacuum suction regulators and multi-parameter monitors produced by Penlon, Ltd.?
Penlon’s vacuum suction regulators are designed for general-purpose medical use, ensuring controlled aspiration during surgical and diagnostic procedures to maintain clear airways and reduce infection risks. Their multi-parameter bedside monitors provide real-time patient data, such as heart rate, blood pressure, and oxygen levels, enabling continuous assessment in critical care environments. Both devices support essential clinical functions in patient safety and procedural efficiency.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- penlon.com
- —
- —
- [email protected]
- Phone
- 800-328-6216
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 458942687
Catalogue (84)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Penlon | 4840-112 | FDA UDI | Class II | Active |
| Penlon | 408001021 | FDA UDI | Class I | Active |
| Penlon | Premier Fibrelight ISO ‘Red’ Handle | FDA UDI | Class I | Active |
| Penlon | 408001019 | FDA UDI | Class I | Active |
| Penlon | 408001006 | FDA UDI | Class I | Active |
| Penlon | Prima 460 | FDA UDI | Class II | Active |
| Penlon | A200SP | FDA UDI | Class I | Active |
| Penlon | 408001002 | FDA UDI | Class I | Active |
| Penlon | Green System MRI Standard Handle | FDA UDI | Class I | Active |
| Penlon | 408001018 | FDA UDI | Class I | Active |
| Penlon | 408001013 | FDA UDI | Class I | Active |
| Penlon | 9510-029 | FDA UDI | Class II | Active |
| Penlon | 310102 | FDA UDI | Class II | Active |
| Penlon | 408001009 | FDA UDI | Class I | Active |
| Penlon | 310023 | FDA UDI | Class II | Active |
| Penlon | 408001010 | FDA UDI | Class I | Active |
| Penlon | 408001020 | FDA UDI | Class I | Active |
| Sigma Elite | K942545 | FDA 510(k) | Class II | Active |
| Sigma Elite | K936046 | FDA 510(k) | Class II | Active |
| Penlon I.d.p. Presssure Failure Alarm | K801254 | FDA 510(k) | Class II | Active |
| Crest Electronic Warming Blanket | K801253 | FDA 510(k) | Class II | Active |
| Penlon Breathing System Pressure Monitor | K902381 | FDA 510(k) | Class II | Active |
| Clm Laryngoscope | K953179 | FDA 510(k) | Class I | Active |
| Av 800 Ventilator | K010317 | FDA 510(k) | Class II | Active |
| Magtarak Respiratory Monitor & Flow Sens | K823555 | FDA 510(k) | Class II | Active |
| Penlon Ppv Vaporizer | K844007 | FDA 510(k) | Class II | Active |
| Ppv Vaporizer (modification) | K960944 | FDA 510(k) | Class II | Active |
| Nuffield Anesthesia Ventilator Ser. 400 | K803052 | FDA 510(k) | Class II | Active |
| Penlon Am1000 Anaesthesia Machine | K844008 | FDA 510(k) | Class II | Active |
| Quik-Fil Vaporizer Keyed Filler | K961468 | FDA 510(k) | Class II | Active |
| Prima Oxygen Monitor | K010318 | FDA 510(k) | Class II | Active |
| Penlon Idp Pressure Failure Alarm | K894689 | FDA 510(k) | Class II | Active |
| Penlon Jumbo Carbon Dioxide Absorber | K801255 | FDA 510(k) | Class I | Active |
| Delta T | K041076 | FDA 510(k) | Class II | Active |
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