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 Sep 01, 2020
Patient Administration Set
K200916
Cyclomedica Australia Pty, Ltd.
Radiology · 148d
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
Cleared Aug 07, 1985
RESPIR GARD-II FACE MASK CORRUGATED TUBING
K853056
Marquest Medical Products, Inc.
Radiology · 19d
Cleared Apr 30, 1985
MEDIPART XENON BREATHING KIT MP-OIXM-I
K850366
Medipart Jerry Alexander
Radiology · 90d

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 →