FDA product code MAA: Monitor, Fetal Doppler Ultrasound
MAA is the FDA product code for monitor, fetal doppler ultrasound. It is a Class II device, regulated under 21 CFR 884.2660 and reviewed by the Radiology panel. FDA has cleared 9 510(k) submissions under MAA, from 7 different applicants. The average 510(k) review took 227 days (median 199). FDA has posted 3 recalls for MAA devices.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Fetal Doppler Ultrasound |
| Device class | Class II |
| Regulation | 21 CFR 884.2660 |
| Review panel | RA — Radiology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MAA clearance
Top MAA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acuson Corp. | 3 | 1991-06-24 |
| Edan Instruments, Inc. | 1 | 2010-10-28 |
| Summit Doppler Systems, Inc. | 1 | 2009-03-31 |
| GE Medical Systems | 1 | 1992-10-20 |
| Toshiba America Medical Systems, In.C | 1 | 1992-04-21 |
2 more applicants have MAA clearances. See the full list in Caduvo.
Most recent MAA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K102138 | Edan Instruments, Inc. | ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER | 2010-10-28 | 90 |
| K090499 | Summit Doppler Systems, Inc. | LIFEDOP MODEL, L350R | 2009-03-31 | 34 |
| K915138 | GE Medical Systems | GE SONOCHROME | 1992-10-20 | 342 |
| K905536 | Toshiba America Medical Systems, In.C | FETAL DOPPLER | 1992-04-21 | 497 |
| K904600 | Acuson Corp. | L582 TRANSDUCER | 1991-06-24 | 257 |
Recalls for MAA devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-12-05.
Frequently asked questions
What is FDA product code MAA?
MAA is the FDA product code for monitor, fetal doppler ultrasound. It is a Class II device, regulated under 21 CFR 884.2660 and reviewed by the Radiology panel.
What device class is MAA?
Class II, regulation 21 CFR 884.2660. Typical premarket route: 510(k).
How long does a 510(k) take for product code MAA?
Across 9 cleared submissions the average was 227 days from receipt to decision (median 199).
Which companies have the most MAA clearances?
Acuson Corp. (3); Edan Instruments, Inc. (1); Summit Doppler Systems, Inc. (1); GE Medical Systems (1); Toshiba America Medical Systems, In.C (1).
Have MAA devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2003-12-05.
Next steps
- Run an FDA pathway report with predicate devices for product code MAA
- Run a recall and safety report across every MAA manufacturer
- Watch product code MAA 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.
All Radiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times