JCE
7 FDA 510(k) clearances · Product code
40 daysmedian time to decision
60 days90th percentile
7clearances measured
FDA profile
- Official device name
- Solution, Isotonic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.4010
- Medical specialty
- Pathology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2024: 21
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 |
|---|---|---|
| BUFFERED SALINE (K842722) | E K Ind., Inc. | 1984-09-11 |
| IMMUNOHEMATOLOGICAL SALINE #97139 (K831200) | Emd Chemicals, Inc. | 1983-05-09 |
| CERTIFIED BLOOD BANK SALINE (K801506) | Nobel Scientific Industries, Inc. | 1980-07-28 |
| COUITER/CMS ISOTONIC BLOOD BANK SALINE (K792101) | Coulter Electronics, Inc. | 1979-11-20 |
| LYSING AGENT AF (K761183) | Central Labs. Assoc. MD Pathologists | 1977-01-17 |
| PHYSIOLOGIC SALINE (0.85%) (K761174) | Bio/Data Corp. | 1977-01-10 |
| BARBITAL SALINE BUFFER (K761170) | Bio/Data Corp. | 1977-01-10 |
Track JCE automatically
Every clearance here is in the API, with alerts when new ones post.