Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

System, Rebreathing, Radionuclide

FDA product code IYT · 49 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1390
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1978-07-17 – 2026-07-07

IYT 2026-07-07

Pulmonex II Xenon System (132-503)

Applicant Mirion Technologies (Capintec), Inc.

K number K253942

View details →

IYT 2020-09-01

Patient Administration Set

Applicant Cyclomedica Australia Pty, Ltd.

K number K200916

View details →

IYT 1995-11-03

XENON CIRCUIT

Applicant King Systems Corp.

K number K953513

View details →

IYT 1995-08-11

XENON GAS BREATHING CIRCUIT

Applicant Intertech Resources, Inc.

K number K952223

View details →

IYT 1992-02-27

XENON CIRCUIT

Applicant Gibeck, Inc.

K number K914747

View details →

IYT 1991-10-28

TETLEY PATIENT ADMINISTRATION SET

Applicant Tetley Medical , Ltd.

K number K913416

View details →

IYT 1991-08-02

BOLUS XENON CIRCUIT

Applicant Vital Signs, Inc.

K number K912626

View details →

IYT 1991-01-14

AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION

Applicant Amici, Inc.

K number K904684

View details →

IYT 1991-01-14

AMICI XENON ADMINISTRATION SET

Applicant Amici, Inc.

K number K903805

View details →

IYT 1990-10-03

AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE

Applicant Amici, Inc.

K number K903694

View details →

IYT 1990-02-26

DISPOSABLE RESPIRTORY KIT (MP-200)

Applicant Medipart Jerry Alexander

K number K896885

View details →

IYT 1990-02-01

MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M

Applicant Medipart Jerry Alexander

K number K896125

View details →

IYT 1990-01-22

DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD

Applicant Medipart Jerry Alexander

K number K896476

View details →

IYT 1990-01-22

DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD

Applicant Medipart Jerry Alexander

K number K896475

View details →

IYT 1990-01-22

MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133

Applicant Medipart Jerry Alexander

K number K896124

View details →

IYT 1988-07-18

AERO-MIST NEBULIZER

Applicant Cadema Medical Products, Inc.

K number K881812

View details →

IYT 1988-04-11

VENTI-SCAN II

Applicant Atomic Products Corp.

K number K871868

View details →

IYT 1988-02-12

AMICI KRYPTON ADMINISTRATION SYSTEM*

Applicant Amici, Inc.

K number K872920

View details →

IYT 1987-10-20

AERO-VENT AEROSOL UNIT

Applicant Medi Nuclear Corp., Inc.

K number K865107

View details →

IYT 1987-03-03

AMICI XENON REBREATHING SYSTEM*

Applicant Amici, Inc.

K number K865084

View details →

IYT 1986-11-04

MODEL XE-103 XENON/MASTER II

Applicant Medi Nuclear Corp., Inc.

K number K863996

View details →

IYT 1986-10-27

VENTICIS II

Applicant Cis-Us, Inc.

K number K863778

View details →

IYT 1986-08-01

MP-070-M RADIOAEROSOL KIT

Applicant Medipart Jerry Alexander

K number K862795

View details →

IYT 1986-08-01

MP-070 RADIOAEROSOL KIT

Applicant Medipart Jerry Alexander

K number K862794

View details →

IYT 1986-08-01

MP-066-M RADIOAEROSOL KIT

Applicant Medipart Jerry Alexander

K number K862793

View details →

IYT 1986-08-01

MP-066 RADIOAEROSOL KIT

Applicant Medipart Jerry Alexander

K number K862792

View details →

IYT 1986-08-01

MP-30XM-IE FACE MASK AND FILTER KIT

Applicant Medipart Jerry Alexander

K number K862791

View details →

IYT 1985-11-07

MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133

Applicant Medipart Jerry Alexander

K number K853579

View details →

IYT 1985-11-07

MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M

Applicant Medipart Jerry Alexander

K number K853576

View details →

IYT 1985-11-07

MEDIPART DRIERITE MP-1002

Applicant Medipart Jerry Alexander

K number K853570

View details →

IYT 1985-09-10

MEDIPART LUND AEROSOL KIT MP-1024A-M

Applicant Medipart Jerry Alexander

K number K851201

View details →

IYT 1985-09-10

MEDIPART LUNG AEROSOL KIT MP-1024A

Applicant Medipart Jerry Alexander

K number K851200

View details →

IYT 1985-09-10

MEDIPART LUNG AEROSOL KIT MP-1012A-M

Applicant Medipart Jerry Alexander

K number K851199

View details →

IYT 1985-09-10

MEDIPART LUNG AEROSOL KIT MP-1012A

Applicant Medipart Jerry Alexander

K number K851198

View details →

IYT 1985-08-19

MEDIPART FACE MASK & FILTER MP-30XM-I

Applicant Medipart Jerry Alexander

K number K850837

View details →

IYT 1985-08-19

MEDIPART FACE MASK MP-XM-I

Applicant Medipart Jerry Alexander

K number K850836

View details →

IYT 1985-08-07

RESPIR GARD-II FACE MASK CORRUGATED TUBING

Applicant Marquest Medical Products, Inc.

K number K853056

View details →

IYT 1985-07-24

XEN-REX I

Applicant Nuclear Pharmacy, Inc.

K number K852693

View details →

IYT 1985-04-30

MEDIPART XENON BREATHING KIT MP-02XM-I

Applicant Medipart Jerry Alexander

K number K850367

View details →

IYT 1985-04-30

MEDIPART XENON BREATHING KIT MP-OIXM-I

Applicant Medipart Jerry Alexander

K number K850366

View details →

IYT 1985-01-14

XENON XE 127/XE 133 GAS DISPENSER

Applicant Mallinckrodt Critical Care

K number K843640

View details →

IYT 1984-12-24

MEDIPART XENON BREATHING KIT MP-01XM

Applicant Medipart Jerry Alexander

K number K844496

View details →

IYT 1984-12-17

MEDIPART XENON BREATHING KIT MP-02XM

Applicant Medipart Jerry Alexander

K number K844495

View details →

IYT 1982-03-31

XENAMATIC SERIES OF XENON REBREATH DEV

Applicant Diversified P.A.

K number K820571

View details →

IYT 1982-03-02

XENON DELIVERY SYSTEM

Applicant Vital Signs, Inc.

K number K820143

View details →

IYT 1981-06-02

KRYPTON MASKS & TUBING

Applicant Medi-Physics Inc. Dba Nycomed Amersham Imaging

K number K811118

View details →

IYT 1981-04-14

MEDI/NUCLEAR #XE-102 XENON/MASTER

Applicant Medi Nuclear Corp., Inc.

K number K810819

View details →

IYT 1978-12-04

DISPENSOR, XENON GAS

Applicant Diagnostic Isotapes, Inc.

K number K781933

View details →

IYT 1978-07-17

DISPENSER, GAS XENON

Applicant Mallinckrodt Critical Care

K number K781107

View details →

↑