FDA product code DPZ: Oximeter, Ear
DPZ is the FDA product code for oximeter, ear. It is a Class II device, regulated under 21 CFR 870.2710 and reviewed by the Anesthesiology panel. FDA has cleared 11 510(k) submissions under DPZ, from 10 different applicants. The average 510(k) review took 74 days (median 77). FDA has posted 12 recalls for DPZ devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Oximeter, Ear |
| Device class | Class II |
| Regulation | 21 CFR 870.2710 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every DPZ clearance
Top DPZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Epic Medical Equipment Services, Inc. | 2 | 2001-10-17 |
| Elekon Industries U.S.A., Inc. | 1 | 2004-12-06 |
| Datex-Ohmeda, Inc. | 1 | 2004-09-02 |
| Nellcor, Inc. | 1 | 1994-10-17 |
| Marquette Electronics, Inc. | 1 | 1994-09-02 |
5 more applicants have DPZ clearances. See the full list in Caduvo.
Most recent DPZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042675 | Elekon Industries U.S.A., Inc. | FLEXI-STAT SP02 EAR SENSOR | 2004-12-06 | 68 |
| K040831 | Datex-Ohmeda, Inc. | DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 | 2004-09-02 | 155 |
| K012333 | Epic Medical Equipment Services, Inc. | FLEXI-SITE SP02 EAR SENSOR | 2001-10-17 | 85 |
| K010718 | Epic Medical Equipment Services, Inc. | FLEXI-SITE SP02 EAR SENSOR | 2001-03-23 | 11 |
| K944760 | Nellcor, Inc. | DURA-Y OXYGEN TRANSDUCER, EAR CLIP | 1994-10-17 | 20 |
Recalls for DPZ devices
12 product recalls in 4 recall events; 9 initiated in the last five years and 9 still open. Most recent: 2023-05-19.
| Year | Recalls |
|---|---|
| 2023 | 9 |
Frequently asked questions
What is FDA product code DPZ?
DPZ is the FDA product code for oximeter, ear. It is a Class II device, regulated under 21 CFR 870.2710 and reviewed by the Anesthesiology panel.
What device class is DPZ?
Class II, regulation 21 CFR 870.2710. Typical premarket route: 510(k).
How long does a 510(k) take for product code DPZ?
Across 11 cleared submissions the average was 74 days from receipt to decision (median 77).
Which companies have the most DPZ clearances?
Epic Medical Equipment Services, Inc. (2); Elekon Industries U.S.A., Inc. (1); Datex-Ohmeda, Inc. (1); Nellcor, Inc. (1); Marquette Electronics, Inc. (1).
Have DPZ devices been recalled?
Yes: 12 product recalls across 4 recall events; the most recent began 2023-05-19.
Next steps
- Run an FDA pathway report with predicate devices for product code DPZ
- Run a recall and safety report across every DPZ manufacturer
- Watch product code DPZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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