IDO
5 FDA 510(k) clearances · Product code
21 daysmedian time to decision
85 days90th percentile
5clearances measured
FDA profile
- Official device name
- Microtome, Rotary
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.3010
- Medical specialty
- Pathology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1999: 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 |
|---|---|---|
| LKB 2260 MACROTOME (K864733) | Lkb Instruments, Inc. | 1987-01-05 |
| ROTARY MICROTOME (K863548) | Surgipath Medical Industries, Inc. | 1986-09-19 |
| LKB 2230 ROTARY ONE (K843505) | Lkb Instruments, Inc. | 1984-11-30 |
| TISSUE-TEK III ACCU-CUT ROTARY MICROTOME (K812558) | Miles Laboratories, Inc. | 1981-09-29 |
| LKB-BROMMA 2218 HISTORANGE MICROTOME (K812157) | Lkb Instruments, Inc. | 1981-08-18 |
Track IDO automatically
Every clearance here is in the API, with alerts when new ones post.