FDA product code OAC: Plethysmograph, Air Displacement For Body Composition Analysis
OAC is the FDA product code for plethysmograph, air displacement for body composition analysis. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 3 510(k) submissions under OAC, from 2 different applicants. The average 510(k) review took 382 days (median 189).
Definition
To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass).
Classification
| Field | Value |
|---|---|
| Device name | Plethysmograph, Air Displacement For Body Composition Analysis |
| Device class | Class II |
| Regulation | 21 CFR 870.2770 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OAC clearance
Top OAC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Life Measurement, Inc. | 2 | 2006-06-27 |
| Life Measurement Instruments, Inc. | 1 | 1995-02-13 |
Most recent OAC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060848 | Life Measurement, Inc. | BOD POD | 2006-06-27 | 91 |
| K032610 | Life Measurement, Inc. | MODIFIED SONAMET BODY COMPOSITION ANALYZER | 2004-03-01 | 189 |
| K924972 | Life Measurement Instruments, Inc. | SONAMET BODY COMPOSITION ANALYZER | 1995-02-13 | 866 |
Recalls for OAC devices
openFDA lists no recalls for product code OAC.
Frequently asked questions
What is FDA product code OAC?
OAC is the FDA product code for plethysmograph, air displacement for body composition analysis. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Obstetrics and Gynecology panel.
What device class is OAC?
Class II, regulation 21 CFR 870.2770. Typical premarket route: 510(k).
How long does a 510(k) take for product code OAC?
Across 3 cleared submissions the average was 382 days from receipt to decision (median 189).
Which companies have the most OAC clearances?
Life Measurement, Inc. (2); Life Measurement Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OAC
- Run a recall and safety report across every OAC manufacturer
- Watch product code OAC 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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