Penlon, Ltd.

ABINGDON Oxfordshire, GB

PENLON LTD. appears in FDA device records in ABINGDON Oxfordshire, GB. FDA records list 22 510(k) clearances between 1980-06-04 and 2006-07-28, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 4 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 22
PMA records: 0
Recall records: 4
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Penlon, Ltd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Penlon, Ltd. (Fmly East Healthcare)recall

510(k) clearance history

FDA records hold 22 510(k) clearances for Penlon, Ltd. between 1980 and 2006. The busiest year on record is 2001, with 3. The most recent is 2006, with 3.

Clearances by year, as a table

510(k) clearance decisions for Penlon, Ltd., by decision year
Year	Clearances
1980	2
1981	2
1983	1
1985	2
1989	1
1990	1
1994	1
1995	2
1996	2
2001	3
2004	1
2005	1
2006	3

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K061102	PRIMA ANAESTHESIA MACHINE	BSZ	Substantially Equivalent	2006-07-28
K060331	SIGMA ALPHA VAPORIZER	CAD	Substantially Equivalent	2006-05-10
K053564	KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454	CAD	Substantially Equivalent	2006-03-03
K051222	AV-S ANAESTHESIA VENTILATOR	CBK	Substantially Equivalent	2005-09-23
K041076	DELTA T	CAD	Substantially Equivalent	2004-08-09
K010318	PRIMA OXYGEN MONITOR	CCL	Substantially Equivalent	2001-07-23
K010317	AV 800 VENTILATOR	CBK	Substantially Equivalent	2001-07-23
K002343	SIGMA DELTA	CAD	Substantially Equivalent	2001-06-08
K961468	QUIK-FIL VAPORIZER KEYED FILLER	CAD	Substantially Equivalent	1996-07-16
K960944	PPV VAPORIZER (MODIFICATION)	CAD	Substantially Equivalent	1996-04-02
K953179	CLM LARYNGOSCOPE	CCW	Substantially Equivalent	1995-10-06
K942545	SIGMA ELITE	CAD	Substantially Equivalent	1995-02-03
K936046	SIGMA ELITE	CAD	Substantially Equivalent	1994-11-04
K902381	PENLON BREATHING SYSTEM PRESSURE MONITOR	CAP	Substantially Equivalent	1990-08-17
K894689	PENLON IDP PRESSURE FAILURE ALARM	CAP	Substantially Equivalent	1989-08-10
K844008	PENLON AM1000 ANAESTHESIA MACHINE	BSZ	Substantially Equivalent	1985-03-12
K844007	PENLON PPV VAPORIZER	CAD	Substantially Equivalent	1985-03-12
K823555	MAGTARAK RESPIRATORY MONITOR & FLOW SENS	BZK	Substantially Equivalent	1983-01-05
K803052	NUFFIELD ANESTHESIA VENTILATOR SER. 400	BSZ	Substantially Equivalent	1981-01-07
K801253	CREST ELECTRONIC WARMING BLANKET	DWJ	Substantially Equivalent	1981-01-02
K801254	PENLON I.D.P. PRESSSURE FAILURE ALARM	CAP	Substantially Equivalent	1980-06-09
K801255	PENLON JUMBO CARBON DIOXIDE ABSORBER	BSF	Substantially Equivalent	1980-06-04

Registered establishments

FDA registered establishments for Penlon, Ltd., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
9610531	3002807907	PENLON LTD.	ABINGDON SCIENCE PARK, ABINGDON Oxfordshire OX14 3NB GB	2026	BSZ BYM CAD CBK CCW GCX

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1653-2013	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.	Class II	2013-05-14	Terminated
Z-1318-2012	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 ventilation.	Penlon, Ltd has identified the potential for the premature failure of a component in some Electronic Flowmeter sensor display unit PCB assemblies.		2011-11-29	Terminated
Z-1221-2012	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.		2011-09-21	Terminated
Z-3213-2011	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.		2011-03-10	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain