IYT · Class II · 21 CFR 892.1390

FDA Product Code IYT: System, Rebreathing, Radionuclide

Leading manufacturers include Medipart Jerry Alexander, Mallinckrodt Critical Care and Vital Signs, Inc..

49
Total
49
Cleared
91d
Avg days
1978
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 210d recently vs 88d historically

FDA 510(k) Cleared System, Rebreathing, Radionuclide Devices (Product Code IYT)

49 devices
1–24 of 49
Cleared Jul 07, 2026
Pulmonex II Xenon System (132-503)
K253942
Mirion Technologies (Capintec), Inc.
Radiology · 210d
Cleared Sep 01, 2020
Patient Administration Set
K200916
Cyclomedica Australia Pty, Ltd.
Radiology · 148d
Cleared Nov 03, 1995
XENON CIRCUIT
K953513
King Systems Corp.
Radiology · 100d
Cleared Aug 11, 1995
XENON GAS BREATHING CIRCUIT
K952223
Intertech Resources, Inc.
Radiology · 91d
Cleared Aug 02, 1991
BOLUS XENON CIRCUIT
K912626
Vital Signs, Inc.
Radiology · 50d
Cleared Feb 26, 1990
DISPOSABLE RESPIRTORY KIT (MP-200)
K896885
Medipart Jerry Alexander
Radiology · 80d
Cleared Feb 01, 1990
MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M
K896125
Medipart Jerry Alexander
Radiology · 101d
Cleared Jan 22, 1990
MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133
K896124
Medipart Jerry Alexander
Radiology · 91d
Cleared Jan 22, 1990
DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD
K896475
Medipart Jerry Alexander
Radiology · 70d
Cleared Jan 22, 1990
DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD
K896476
Medipart Jerry Alexander
Radiology · 70d
Cleared Aug 01, 1986
MP-30XM-IE FACE MASK AND FILTER KIT
K862791
Medipart Jerry Alexander
Radiology · 9d
Cleared Aug 01, 1986
MP-066 RADIOAEROSOL KIT
K862792
Medipart Jerry Alexander
Radiology · 9d
Cleared Aug 01, 1986
MP-066-M RADIOAEROSOL KIT
K862793
Medipart Jerry Alexander
Radiology · 9d
Cleared Aug 01, 1986
MP-070 RADIOAEROSOL KIT
K862794
Medipart Jerry Alexander
Radiology · 9d
Cleared Aug 01, 1986
MP-070-M RADIOAEROSOL KIT
K862795
Medipart Jerry Alexander
Radiology · 9d
Cleared Nov 07, 1985
MEDIPART DRIERITE MP-1002
K853570
Medipart Jerry Alexander
Radiology · 73d
Cleared Nov 07, 1985
MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M
K853576
Medipart Jerry Alexander
Radiology · 73d
Cleared Nov 07, 1985
MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133
K853579
Medipart Jerry Alexander
Radiology · 73d
Cleared Sep 10, 1985
MEDIPART LUNG AEROSOL KIT MP-1012A
K851198
Medipart Jerry Alexander
Radiology · 168d
Cleared Sep 10, 1985
MEDIPART LUNG AEROSOL KIT MP-1012A-M
K851199
Medipart Jerry Alexander
Radiology · 168d
Cleared Sep 10, 1985
MEDIPART LUNG AEROSOL KIT MP-1024A
K851200
Medipart Jerry Alexander
Radiology · 168d
Cleared Sep 10, 1985
MEDIPART LUND AEROSOL KIT MP-1024A-M
K851201
Medipart Jerry Alexander
Radiology · 168d
Cleared Aug 19, 1985
MEDIPART FACE MASK MP-XM-I
K850836
Medipart Jerry Alexander
Radiology · 171d
Cleared Aug 19, 1985
MEDIPART FACE MASK & FILTER MP-30XM-I
K850837
Medipart Jerry Alexander
Radiology · 171d

About Product Code IYT - Regulatory Context

510(k) Submission Activity

49 total 510(k) submissions under product code IYT since 1978, with 49 receiving FDA clearance (average review time: 91 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - IYT Product Code

Recent submissions under IYT have taken an average of 210 days to reach a decision - up from 88 days historically. Manufacturers should account for longer review timelines in current project planning.

IYT devices are reviewed by the Radiology panel. Browse all Radiology devices →