DPZ
11 FDA 510(k) clearances · Product code
77 daysmedian time to decision
147 days90th percentile
11clearances measured
FDA profile
- Official device name
- Oximeter, Ear
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2710
- Medical specialty
- Cardiovascular
- Adverse events (MAUDE)
- 2005: 4 · 2011: 13 · 2012: 4 · 2013: 22 · 2014: 43
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 |
|---|---|---|
| FLEXI-STAT SP02 EAR SENSOR (K042675) | Elekon Industries U.S.A., Inc. | 2004-12-06 |
| DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (K040831) | Datex-Ohmeda, Inc. | 2004-09-02 |
| FLEXI-SITE SP02 EAR SENSOR (K012333) | Epic Medical Equipment Services, Inc. | 2001-10-17 |
| FLEXI-SITE SP02 EAR SENSOR (K010718) | Epic Medical Equipment Services, Inc. | 2001-03-23 |
| DURA-Y OXYGEN TRANSDUCER, EAR CLIP (K944760) | Nellcor, Inc. | 1994-10-17 |
| MARQUETTE EAR PROBE SENSOR (K942752) | Marquette Electronics, Inc. | 1994-09-02 |
| PULSE RATE MONITOR (K914595) | Fitness Quest, Inc. | 1992-01-31 |
| PULSE OXIMETER (K862426) | Draeger Medical, Inc. | 1986-09-11 |
| VITALOG PMS-8 (K845051) | Vitalog Corp. | 1985-05-15 |
| OHMEDA BIOX 3700 PULSE OXIMETER (K850494) | Ohmeda Medical | 1985-03-28 |
| EAR OXIMETER (K810363) | Bio-Tek Instruments, Inc. | 1981-02-27 |
Track DPZ automatically
Every clearance here is in the API, with alerts when new ones post.