FDA product code DOP: Mass Spectrometer, Clinical Use
DOP is the FDA product code for mass spectrometer, clinical use. It is a Class I device, regulated under 21 CFR 862.2860 and reviewed by the Clinical Toxicology panel. FDA has cleared 10 510(k) submissions under DOP, from 7 different applicants. The average 510(k) review took 55 days (median 56). FDA has posted 16 recalls for DOP devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Mass Spectrometer, Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2860 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DOP clearance
Top DOP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Finnigan Corp. | 3 | 1988-05-31 |
| The Perkin-Elmer Corp. | 2 | 1987-08-11 |
| Pdz-Europa , Ltd. | 1 | 1999-07-13 |
| Europa Scientific, Ltd. | 1 | 1997-12-16 |
| Airspec , Ltd. | 1 | 1985-12-11 |
2 more applicants have DOP clearances. See the full list in Caduvo.
Most recent DOP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992163 | Pdz-Europa , Ltd. | ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS | 1999-07-13 | 18 |
| K974322 | Europa Scientific, Ltd. | ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM | 1997-12-16 | 29 |
| K880418 | Finnigan Corp. | INCOS 50 MASS SPECTROMETER | 1988-05-31 | 120 |
| K880090 | Finnigan Corp. | ION TRAP DETECTOR | 1988-03-15 | 63 |
| K880089 | Finnigan Corp. | FINNIGAN MAT TSQ-70 | 1988-02-11 | 30 |
Recalls for DOP devices
16 product recalls in 10 recall events; 5 initiated in the last five years and 4 still open. Most recent: 2023-08-30.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2021 | 2 |
| 2023 | 4 |
Frequently asked questions
What is FDA product code DOP?
DOP is the FDA product code for mass spectrometer, clinical use. It is a Class I device, regulated under 21 CFR 862.2860 and reviewed by the Clinical Toxicology panel.
What device class is DOP?
Class I, regulation 21 CFR 862.2860. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DOP?
Across 10 cleared submissions the average was 55 days from receipt to decision (median 56).
Which companies have the most DOP clearances?
Finnigan Corp. (3); The Perkin-Elmer Corp. (2); Pdz-Europa , Ltd. (1); Europa Scientific, Ltd. (1); Airspec , Ltd. (1).
Have DOP devices been recalled?
Yes: 16 product recalls across 10 recall events; the most recent began 2023-08-30.
Next steps
- Run an FDA pathway report with predicate devices for product code DOP
- Run a recall and safety report across every DOP manufacturer
- Watch product code DOP 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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