Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610531

FEI Number

3002807907

Entity Name

PENLON LTD.

City/State/Country

ABINGDON Oxfordshire, GB

Establishment Address

ABINGDON SCIENCE PARK, BARTON LANE, ABINGDON Oxfordshire OX14 3NB, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PENLON LTD. (Owner Number: 9029886)

Owner / Operator Contact Address

ABINGDON SCIENCE PARK, BARTON LANE, ABINGDON, GB-NOTA OX14 3NB, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K961468

PMA Number

N/A

All Registered Proprietary Names

PENLON SUCTION CONTROLLER RANGE AV-S MRI Anaesthesia Ventilator AV-S Anaesthesia Ventilator AV-S Anaesthesia Combined Ventilator AV-S Anaesthesia Remote Ventilator Penlon Crystal Metal Disposable Laryngoscope Handles & Bulbs Penlon Diamond MRI Laryngoscope Blades, Handles & Bulbs Penlon Green MRI Laryngoscope Blades, Handles & Bulbs Penlon Diamond Laryngoscope Blades, Handles & Bulbs (Green) PENLON LARYNGOSCOPE RANGE Sigma Delta Keyed Filler Bottle Adapter Keyed Filler Bottle Adaptor Isoflurane Keyed Filler Bottle Adaptor Halothane Keyed Filler Bottle Adaptor Sevoflurane Quik-Fil Vaporizer Keyed Filler

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2003-03-17
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2007-11-19
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2002-04-24
CAD	Vaporizer, Anesthesia, Non-Heated	Anesthesiology	Class 2	868.5880	2007-11-19
CAD	Vaporizer, Anesthesia, Non-Heated	Anesthesiology	Class 2	868.5880	2007-11-19

Official Correspondent

No official correspondent registered.

US Agent Details

Brent Kramer Business: DRE Resume, LLC Email: Brent.kramer@dremed.com Phone: (502) 2444444

Related Public Records

Same Entity

PENLON LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610531. Last updated year: 2026. Please use registration number 9610531 when referencing this establishment in official correspondence.