Product Code: CAD FDA class 2 21 CFR 868.5880

Vaporizer, Anesthesia, Non-Heated

Anesthesiology

The Non-Heated Anesthesia Vaporizer is a device used in anesthesiology to deliver precise concentrations of volatile anesthetic agents to patients during surgical procedures, without the use of a heating element. It is classified as FDA Class 2 (moderate risk), meaning it requires 510(k) premarket notification before marketing, demonstrating substantial equivalence to a legally marketed predicate device. The product code is CAD, regulated under 21 CFR 868.5880, within the Anesthesiology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CAD
Device Class: FDA class 2
Regulation Number: 868.5880
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 57 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240375	V80 Anesthetic Vaporizer (V80)	Oct 31, 2024	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K172702	Tec 820, Tec 850	Jan 04, 2018	Substantially Equivalent	Datex-Ohmeda, Inc.
K150167	V60 Anesthetic Vaporizer	Jun 30, 2015	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K110608	SEVOFLURANE VAPORIZER ADAPTOR	Jul 20, 2011	Substantially Equivalent	Piramal Critcal Care, Inc (Formerly Minrad, Inc)
K060331	SIGMA ALPHA VAPORIZER	May 10, 2006	Substantially Equivalent	Penlon Limited
K053564	KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454	Mar 03, 2006	Substantially Equivalent	Penlon Limited
K051666	GAV - GENERAL ANAESTHETIC VAPORIZER	Aug 23, 2005	Substantially Equivalent	General Anaesthetic Services Limited
K042276	D-VAPOR	Sep 23, 2004	Substantially Equivalent	Draeger Medical, Inc.
K041076	DELTA T	Aug 09, 2004	Substantially Equivalent	Penlon , Ltd.
K031027	DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)	Jun 26, 2003	Substantially Equivalent	Datex-Ohmeda, Inc.
K012924	DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER	Jan 30, 2002	Substantially Equivalent	Datex-Ohmeda, Inc.
K002343	SIGMA DELTA	Jun 08, 2001	Substantially Equivalent	Penlon , Ltd.
K002878	DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER	Sep 21, 2000	Substantially Equivalent	Datex-Ohmeda, Inc.
K000275	DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA	Apr 12, 2000	Substantially Equivalent	Datex-Ohmeda, Inc.
K990132	DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC	Jan 21, 1999	Substantially Equivalent	Datex-Ohmeda, Inc.
K980489	VAPAMASTA 6	Aug 31, 1998	Substantially Equivalent	Medical Industrial Equipment
K980884	SIEMENS SEVOFLURANE VAPORIZER SV 953	Aug 19, 1998	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K981773	DRAGER-VAPOR 19.3	Jul 06, 1998	Substantially Equivalent	Draeger Medical, Inc.
K981472	DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS	May 07, 1998	Substantially Equivalent	Draeger Medical, Inc.
K973051	DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS	Oct 30, 1997	Substantially Equivalent	Draeger Medical, Inc.
K971923	DRAGER-VAPOR 2000	Sep 16, 1997	Substantially Equivalent	Draeger Medical, Inc.
K952083	TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE	Oct 21, 1996	Substantially Equivalent	Clover Medical Equipment Services, Inc.
K961468	QUIK-FIL VAPORIZER KEYED FILLER	Jul 16, 1996	Substantially Equivalent	Penlon , Ltd.
K960944	PPV VAPORIZER (MODIFICATION)	Apr 02, 1996	Substantially Equivalent	Penlon , Ltd.
K954801	TECHFIL	Jan 25, 1996	Substantially Equivalent	Technimeca Medic, Inc.
K953748	TECHNOFIL	Jan 25, 1996	Substantially Equivalent	Technimeca Medic, Inc.
K942799	DATUM	Apr 13, 1995	Substantially Equivalent	Blease USA, Inc.
K942091	OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE	Mar 30, 1995	Substantially Equivalent	Ohmeda Medical
K945993	VAPOFIL	Feb 22, 1995	Substantially Equivalent	Southmedic, Inc.
K942545	SIGMA ELITE	Feb 03, 1995	Substantially Equivalent	Penlon , Ltd.
K942055	DRAGER-VAPOR 19.1	Jan 27, 1995	Substantially Equivalent	North American Grager
K936046	SIGMA ELITE	Nov 04, 1994	Substantially Equivalent	Penlon, Inc.
K923265	FUNNEL ADAPTOR	Mar 18, 1993	Substantially Equivalent	Southmedic, Inc.
K913593	OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER	Oct 06, 1992	Substantially Equivalent	Ohmeda Medical
K892057	OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER	Apr 26, 1989	Substantially Equivalent	Ohmeda Medical
K884686	VAPAMASTA 5	Mar 15, 1989	Substantially Equivalent	Dentsply Intl.
K884090	LUNDY VAPORIZER SYSTEM	Jan 24, 1989	Substantially Equivalent	Vaporflow Technology, Inc.
K882500	VAPORIZER, ANESTHESIA, NON-HEATED	Aug 01, 1988	Substantially Equivalent	Anesthetic Vaporizer Services
K872053	KEYFILL	Jul 01, 1987	Substantially Equivalent	Mayfield Instruments, Ltd.
K864605	VAPLOK	Feb 03, 1987	Substantially Equivalent	Bear Medical Systems, Inc.
K861839	VAPOFIL	May 21, 1986	Substantially Equivalent	Southmedic, Inc.
K860545	VAPORIZER SPACER	Apr 17, 1986	Substantially Equivalent	Southmedic, Inc.
K854202	ANESTHESIA VENTILATOR MODEL 100	Apr 11, 1986	Substantially Equivalent	Rusz Instruments, Inc.
K844007	PENLON PPV VAPORIZER	Mar 12, 1985	Substantially Equivalent	Penlon, Inc.
K843993	ANAESLOCK THREE VAPORIZER INTERLOCK HVA003	Nov 15, 1984	Substantially Equivalent	Southmedic, Inc.
K841157	HALOTHANE VAPORIZER 950, ENFLURANE	Jun 07, 1984	Substantially Equivalent	Siemens Elema AB
K831427	CYPRANE TEC 4 CONTINUOUS FLOW VAPOR.	Jul 07, 1983	Substantially Equivalent	Fraser Harlake, Inc.
K821966	MODULUS VERNI-TROL ANESTHETIC VAPORIZER	Jul 16, 1982	Substantially Equivalent	Ohio Medical Products
K821650	DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS	Jun 29, 1982	Substantially Equivalent	Draeger Medical, Inc.
K810289	MODULUS VERNI-TROL ANESTHETIC VAPORIZER	Mar 04, 1981	Substantially Equivalent	Ohio Medical Products
K790359	HALOTHANE VAPORIZER 950, & ENFLURANE 951	Mar 21, 1979	Substantially Equivalent	Siemens Corp.
K771892	VALVE ANESTHETIC	Feb 02, 1978	Substantially Equivalent	Promed Corp.
K771899	VAPOR 19	Oct 18, 1977	Substantially Equivalent	Draeger Medical, Inc.
K771150	COPPER KETTLE VAPORIZER PLUS	Aug 04, 1977	Substantially Equivalent	Air Products & Chemicals, Inc.
K770021	MASK, FACE, SURGICAL	Jan 17, 1977	Substantially Equivalent	Precept, Inc.
K761160	MODEL CNA-1 VAPORIZER	Dec 09, 1976	Substantially Equivalent	Cyprane North America, Inc.
K760668	SELECTATEC SYSTEM	Sep 27, 1976	Substantially Equivalent	Medishield, Inc.