IKY
8 FDA 510(k) clearances · Product code
22 daysmedian time to decision
129 days90th percentile
8clearances measured
FDA profile
- Official device name
- Mattress, Flotation Therapy, Non-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5150
- Medical specialty
- General Hospital
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2020: 16 · 2021: 13 · 2022: 44 · 2023: 23 · 2024: 433 · 2025: 39
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 |
|---|---|---|
| SCM-3 AND ACCESSORIES (K914921) | Gaymar Industries, Inc. | 1992-03-12 |
| GEL FLOTATION MATTRESS (K813226) | Jefferson Industries, Inc. | 1981-12-02 |
| TETRA NATAL-MAT WATER FLOTATION MAT. (K802833) | Tetra Group U.S.A., Inc. | 1980-12-10 |
| BEDDING PADS EGGCREATE PADS (K802781) | Leemart Bedding Mfg. Co. | 1980-12-10 |
| ECONO-FLOAT WATER FLOTATION MATTRESS (K780779) | Jefferson Industries, Inc. | 1978-05-19 |
| NEONATAL FLOTATION SYSTEM (K772062) | Medpro, Inc. | 1977-11-15 |
| MEDPRO FLOTATION SYSTEM (K771824) | Medpro, Inc. | 1977-10-19 |
| DECUBITUS MATTRESS (K760963) | Arco Medical Products Co. | 1976-11-18 |
Track IKY automatically
Every clearance here is in the API, with alerts when new ones post.