JOD
12 FDA 510(k) clearances · Product code
63 daysmedian time to decision
154 days90th percentile
12clearances measured
FDA profile
- Official device name
- Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4270
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2001: 1 · 2007: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GAS FILTER (K993060) | Olson Medical Sales, Inc. | 2000-03-28 |
| CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS (K890504) | Gish Biomedical, Inc. | 1989-03-10 |
| PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE (K875095) | Pall Biomedical Products Co. | 1988-02-29 |
| PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE (K874405) | Pall Biomedical Products Co. | 1987-12-30 |
| SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 (K855067) | Cobe Laboratories, Inc. | 1986-02-26 |
| CARDIO METRICS CARDIOTOMY RESERVOIR (K841958) | Sterile Design, Inc. | 1984-10-15 |
| CARDIOTOMY FILTER (K830634) | Texas Medical Products, Inc. | 1983-06-30 |
| INTERFACE CARDIOTOMY BLOOD FILTER #50 (K823259) | Medical, Inc. | 1982-11-24 |
| INTERFACE CARDIOTOMY BLOOD FILTER #51 (K823260) | Medical, Inc. | 1982-11-24 |
| INTERFACE CARDIOTOMY BLOOD FILTER #51 (K812243) | Medical, Inc. | 1981-08-25 |
| INTERFACE CARDIOTOMY BLOOD FILTER (K781383) | Medical, Inc. | 1978-09-27 |
| EXTRACORPEAL CARDIOTOMY BLOOD FILTER (K780653) | Cobe Laboratories, Inc. | 1978-06-14 |
Track JOD automatically
Every clearance here is in the API, with alerts when new ones post.