DSJ
6 FDA 510(k) clearances · Product code
98 daysmedian time to decision
230 days90th percentile
6clearances measured
FDA profile
- Official device name
- Alarm, Blood-Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1100
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2021: 32 · 2022: 27 · 2023: 16 · 2024: 30
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 |
|---|---|---|
| EarlyVue VS30 (K190624) | Philips Medizin Systeme Boeblingen GmbH | 2019-10-27 |
| SureSigns VS3; SureSigns VS4 (K163649) | Philips Medical Systems | 2017-03-31 |
| SureSigns VS3, SureSigns VS4 (K151761) | Phillips Medical Systems | 2015-09-29 |
| SURESIGNS VS3, SURESIGNS VS4 (K133961) | Philips Medical Systems | 2014-06-26 |
| SAMS 8000 CARDIOPLEGIA MONITOR (K960916) | 3M Health Care, Sarns | 1996-06-04 |
| KELLER VITAL SIGNS MONITOR - KMS-890 (K910262) | Keller Medical Specialties Products, Inc. | 1991-04-01 |
Track DSJ automatically
Every clearance here is in the API, with alerts when new ones post.