HCS
8 FDA 510(k) clearances · Product code
69 daysmedian time to decision
251 days90th percentile
8clearances measured
FDA profile
- Official device name
- Device, Temperature Measurement, Direct Contact, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1570
- Medical specialty
- Neurology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 1 · 1999: 2 · 2007: 2
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 |
|---|---|---|
| POS T-7000 (K981805) | Pos Technologies, Inc. | 1998-08-07 |
| TYTRON C-3000 (K974208) | Titronics Research & Development Co. | 1998-02-03 |
| NEUROREADER (K950986) | Artronics | 1995-11-09 |
| THERMALGRAPHIC ANALYSER (K894772) | Medtech Instruments | 1989-10-03 |
| T-METER (K840487) | K.J. Electronics | 1984-03-12 |
| TRENDO-SCOPE (K831995) | Gabriel Ent. | 1983-08-08 |
| GABRIEL DIGITREND (K822795) | Gabriel Ent. | 1982-10-08 |
| EXOPHTHALMOMETER (K821107) | Medical Equipment Designs, Inc. | 1982-06-14 |
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Every clearance here is in the API, with alerts when new ones post.