Patient Administration Set
FDA 510(k) clearance K200916 · decided 2020-09-01
Clearance details
- K-number
- K200916
- Device name
- Patient Administration Set
- Applicant
- Cyclomedica Australia Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-06
- Decision date
- 2020-09-01
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- IYT
- Device class
- 2
- Regulation number
- 892.1390
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Kingsgrove, AU
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Pulmonex II Xenon System (132-503) (K253942) | Mirion Technologies (Capintec), Inc. | 2026-07-07 |
| 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 Alexander | 1990-02-26 |
| MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M (K896125) | Medipart Jerry Alexander | 1990-02-01 |
| DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD (K896476) | Medipart Jerry Alexander | 1990-01-22 |
Recalls involving this device
No recalls on record reference this clearance.