LRT
5 FDA 510(k) clearances · Product code
270 daysmedian time to decision
528 days90th percentile
5clearances measured
FDA profile
- Official device name
- Indicator, Sterilization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Medical specialty
- General Hospital
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1996: 1
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 |
|---|---|---|
| TST CONTROL INTEGRATOR FOR STEAM STERILIZERS (K002937) | Albert Browne , Ltd. | 2001-11-05 |
| TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE (K965154) | Albert Browne , Ltd. | 1997-09-19 |
| CROSS-CHECKS (K951113) | Steritec Products Mfg Co, Inc. | 1996-08-19 |
| TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS (K951703) | Products For Medicine | 1995-06-28 |
| STERILIZATION INDICATOR FOR FLASH STERILIZATION (K871672) | Propper Mfg. Co., Inc. | 1987-06-01 |
Track LRT automatically
Every clearance here is in the API, with alerts when new ones post.