IEO
12 FDA 510(k) clearances · Product code
62 daysmedian time to decision
109 days90th percentile
12clearances measured
FDA profile
- Official device name
- Processor, Tissue, Automated
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.3875
- Medical specialty
- Pathology
- Adverse events (MAUDE)
- 2021: 126 · 2022: 169 · 2023: 67 · 2024: 63 · 2025: 68 · 2026: 26
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 |
|---|---|---|
| MICROWAVE AUTOMATED TISSUE PROCESSOR (K924590) | Innovative Medical Systems, Inc. | 1992-12-29 |
| LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) (K883599) | Innovative Medical Systems, Inc. | 1988-09-02 |
| SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR (K881165) | Sakura Finetek U.S.A., Inc. | 1988-07-01 |
| LX 300 TISSUE PROCESSOR (K853938) | Innovative Medical Systems, Inc. | 1985-10-10 |
| LX120 TISSUE PROCESSOR (K851054) | Innovative Medical Systems, Inc. | 1985-05-15 |
| LKB 2189 ULTROPROCESSOR (K843506) | Lkb Instruments, Inc. | 1984-11-30 |
| AUTOTECHNICON V TISSUE PROCESS SYS (K834599) | Technicon Instruments Corp. | 1984-02-04 |
| TISSUE-TEK V.I.P. 100/200 (K831313) | Miles Laboratories, Inc. | 1983-07-28 |
| TISSUE-TEK III MINI-RAPID PROCESSOR (K801427) | Miles Laboratories, Inc. | 1980-07-28 |
| TISSUE PROCESSING SYSTEM (K801513) | Innovative Medical Systems, Inc. | 1980-07-28 |
| TISSUE-TEK III V.I.P. (K771308) | Miles Laboratories, Inc. | 1977-08-22 |
| HISTO-TEK W/ AUTOMATIC COVERSLIPPER (K761062) | Miles Laboratories, Inc. | 1977-03-07 |
Track IEO automatically
Every clearance here is in the API, with alerts when new ones post.