EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control
FDA 510(k) clearance K151978 · decided 2016-07-15
Clearance details
- K-number
- K151978
- Device name
- EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control
- Applicant
- Edan Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-07-17
- Decision date
- 2016-07-15
- Days to decision
- 364 days
- Clearance type
- Traditional
- Product code
- CHL
- Device class
- 2
- Regulation number
- 862.1120
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Edan Instruments
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ABL90 FLEX PLUS System, safeCLINITUBES (K252207) | Radiometer Medicals Aps | 2026-04-10 |
| i-STAT CG4+ cartridge with the i-STAT 1 System (K244014) | Abbott Point of Care, Inc. | 2025-05-02 |
| ABL90 FLEX PLUS System (K240998) | Radiometer Medicals Aps | 2024-12-13 |
| i-STAT CG8+ cartridge with the i-STAT 1 System (K230285) | Abbott Point of Care, Inc. | 2023-10-27 |
| Stat Profile Prime Plus Analyzer System (K221900) | Nova Biomedical Corporation | 2023-09-29 |
| i-STAT G3+ cartridge with the i-STAT 1 System (K223857) | Abbott Point of Care, Inc. | 2023-09-15 |
| GEM Premier 7000 with IQM3 (K223608) | Instrumentation Laboratory Company | 2023-08-10 |
| EasyStat 300 (K211559) | Medica Corporation | 2023-01-27 |
| GEM Premier 5000 (K203790) | Instrumentation Laboratory CO | 2021-08-20 |
| OPTI® B-Lac Cassette (K200986) | Opti Medical Systems, Inc. | 2021-08-02 |
| epoc Blood Analysis System (K200107) | Epocal, Inc. | 2020-06-05 |
| i-STAT CG4+ Cartridge with the i-STAT 1 System (K200492) | Abbott Point of Care, Inc. | 2020-04-09 |
Recalls involving this device
No recalls on record reference this clearance.