Medical Device Manufacturer · GB , Abingdon Ox

Penlon , Ltd. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1995

Recent clearances: PRIMA ANAESTHESIA MACHINE, DELTA T, AV 800 VENTILATOR

9
Total
9
Cleared
0
Denied

Penlon, Ltd. is a British medical device manufacturer established in Oxford in 1943. The company develops, manufactures, and exports anesthesiology and related medical products to over ninety countries worldwide. Penlon operates with a manufacturing facility in Abingdon, Oxfordshire, United Kingdom.

Penlon has received 9 FDA 510(k) clearances from 9 total submissions since 1995. All submissions focused on anesthesiology devices, reflecting the company's core specialization. The latest clearance was granted in 2006. Penlon is currently inactive in the FDA 510(k) program and should be treated as a historical regulatory record.

The company's cleared device portfolio includes anesthesia delivery systems, vaporizers, ventilators, oxygen monitors, and airway management tools such as laryngoscopes. These products represent foundational technologies in perioperative care and anesthetic administration.

Explore the complete regulatory history, including individual device names, product codes, and clearance dates, in the database records below.

FDA 510(k) Regulatory Record - Penlon , Ltd.

9 devices
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