KSS
6 FDA 510(k) clearances · Product code
22 daysmedian time to decision
69 days90th percentile
6clearances measured
FDA profile
- Official device name
- Supplies, Blood-Bank
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.9050
- Medical specialty
- Hematology
- Adverse events (MAUDE)
- 1996: 1 · 2000: 1 · 2002: 2 · 2006: 3 · 2007: 3 · 2008: 4
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 |
|---|---|---|
| FLUID SAMPLING PACK (K874436) | U.S. Mfg. & Management, Inc. | 1988-01-05 |
| S/P SERUM DROPPER PIPETS (K812892) | American Dade | 1981-10-27 |
| PRE-DENT SYSTEM OR PRE-DENT II (K801386) | Pre-Dent System | 1980-07-14 |
| PRE-DENT SYSTEM MODIFIED (K801516) | Pre-Dent System | 1980-07-14 |
| PRE-DENT SYSTEM (K800736) | Pre-Dent System | 1980-04-24 |
| IMMU-SAL IMMUNOHEMATOLOGICAL SALINE (K761303) | Dade, Baxter Travenol Diagnostics, Inc. | 1976-12-30 |
Track KSS automatically
Every clearance here is in the API, with alerts when new ones post.