Atlas FDA

IYT

49 FDA 510(k) clearances · Product code

73 daysmedian time to decision
171 days90th percentile
49clearances measured

FDA profile

Official device name
System, Rebreathing, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1390
Medical specialty
Radiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1998: 2 · 2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Pulmonex II Xenon System (132-503) (K253942)Mirion Technologies (Capintec), Inc.2026-07-07
Patient Administration Set (K200916)Cyclomedica Australia Pty, Ltd.2020-09-01
XENON CIRCUIT (K953513)King Systems Corp.1995-11-03
XENON GAS BREATHING CIRCUIT (K952223)Intertech Resources, Inc.1995-08-11
XENON CIRCUIT (K914747)Gibeck, Inc.1992-02-27
TETLEY PATIENT ADMINISTRATION SET (K913416)Tetley Medical , Ltd.1991-10-28
BOLUS XENON CIRCUIT (K912626)Vital Signs, Inc.1991-08-02
AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION (K904684)Amici, Inc.1991-01-14
AMICI XENON ADMINISTRATION SET (K903805)Amici, Inc.1991-01-14
AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE (K903694)Amici, Inc.1990-10-03
DISPOSABLE RESPIRTORY KIT (MP-200) (K896885)Medipart Jerry Alexander1990-02-26
MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M (K896125)Medipart Jerry Alexander1990-02-01
DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD (K896476)Medipart Jerry Alexander1990-01-22
DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD (K896475)Medipart Jerry Alexander1990-01-22
MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 (K896124)Medipart Jerry Alexander1990-01-22
AERO-MIST NEBULIZER (K881812)Cadema Medical Products, Inc.1988-07-18
VENTI-SCAN II (K871868)Atomic Products Corp.1988-04-11
AMICI KRYPTON ADMINISTRATION SYSTEM* (K872920)Amici, Inc.1988-02-12
AERO-VENT AEROSOL UNIT (K865107)Medi Nuclear Corp., Inc.1987-10-20
AMICI XENON REBREATHING SYSTEM* (K865084)Amici, Inc.1987-03-03
MODEL XE-103 XENON/MASTER II (K863996)Medi Nuclear Corp., Inc.1986-11-04
VENTICIS II (K863778)Cis-Us, Inc.1986-10-27
MP-066 RADIOAEROSOL KIT (K862792)Medipart Jerry Alexander1986-08-01
MP-070 RADIOAEROSOL KIT (K862794)Medipart Jerry Alexander1986-08-01
MP-30XM-IE FACE MASK AND FILTER KIT (K862791)Medipart Jerry Alexander1986-08-01
MP-070-M RADIOAEROSOL KIT (K862795)Medipart Jerry Alexander1986-08-01
MP-066-M RADIOAEROSOL KIT (K862793)Medipart Jerry Alexander1986-08-01
MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M (K853576)Medipart Jerry Alexander1985-11-07
MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133 (K853579)Medipart Jerry Alexander1985-11-07
MEDIPART DRIERITE MP-1002 (K853570)Medipart Jerry Alexander1985-11-07
MEDIPART LUNG AEROSOL KIT MP-1012A (K851198)Medipart Jerry Alexander1985-09-10
MEDIPART LUNG AEROSOL KIT MP-1012A-M (K851199)Medipart Jerry Alexander1985-09-10
MEDIPART LUNG AEROSOL KIT MP-1024A (K851200)Medipart Jerry Alexander1985-09-10
MEDIPART LUND AEROSOL KIT MP-1024A-M (K851201)Medipart Jerry Alexander1985-09-10
MEDIPART FACE MASK MP-XM-I (K850836)Medipart Jerry Alexander1985-08-19
MEDIPART FACE MASK & FILTER MP-30XM-I (K850837)Medipart Jerry Alexander1985-08-19
RESPIR GARD-II FACE MASK CORRUGATED TUBING (K853056)Marquest Medical Products, Inc.1985-08-07
XEN-REX I (K852693)Nuclear Pharmacy, Inc.1985-07-24
MEDIPART XENON BREATHING KIT MP-02XM-I (K850367)Medipart Jerry Alexander1985-04-30
MEDIPART XENON BREATHING KIT MP-OIXM-I (K850366)Medipart Jerry Alexander1985-04-30
XENON XE 127/XE 133 GAS DISPENSER (K843640)Mallinckrodt Critical Care1985-01-14
MEDIPART XENON BREATHING KIT MP-01XM (K844496)Medipart Jerry Alexander1984-12-24
MEDIPART XENON BREATHING KIT MP-02XM (K844495)Medipart Jerry Alexander1984-12-17
XENAMATIC SERIES OF XENON REBREATH DEV (K820571)Diversified P.A.1982-03-31
XENON DELIVERY SYSTEM (K820143)Vital Signs, Inc.1982-03-02
KRYPTON MASKS & TUBING (K811118)Medi-Physics Inc. Dba Nycomed Amersham Imaging1981-06-02
MEDI/NUCLEAR #XE-102 XENON/MASTER (K810819)Medi Nuclear Corp., Inc.1981-04-14
DISPENSOR, XENON GAS (K781933)Diagnostic Isotapes, Inc.1978-12-04
DISPENSER, GAS XENON (K781107)Mallinckrodt Critical Care1978-07-17

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Every clearance here is in the API, with alerts when new ones post.