FDA product code OED: Antimicrobial Blood Pressure Cuff
OED is the FDA product code for antimicrobial blood pressure cuff. It is a Class II device, regulated under 21 CFR 870.1120 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under OED, from 2 different applicants. The average 510(k) review took 233 days (median 233).
Definition
Device is a replacement cuff to be used in conjunction with a non-invasive blood pressure monitor. Together the devices determine blood pressures and heart rate. This particular cuff contains an embedded antimicrobial. A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Classification
| Field | Value |
|---|---|
| Device name | Antimicrobial Blood Pressure Cuff |
| Device class | Class II |
| Regulation | 21 CFR 870.1120 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OED clearance
Top OED applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Statcorp Medical | 1 | 2013-06-04 |
| Philips Medical Systems | 1 | 2007-12-20 |
Most recent OED clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122365 | Statcorp Medical | ULTRACHECK CURVE BLOOD PRESSURE CUFFS | 2013-06-04 | 302 |
| K071885 | Philips Medical Systems | ANTIMICROBIAL AND SINGLE-PATIENT CUFFS | 2007-12-20 | 164 |
Recalls for OED devices
openFDA lists no recalls for product code OED.
Frequently asked questions
What is FDA product code OED?
OED is the FDA product code for antimicrobial blood pressure cuff. It is a Class II device, regulated under 21 CFR 870.1120 and reviewed by the Cardiovascular panel.
What device class is OED?
Class II, regulation 21 CFR 870.1120. Typical premarket route: 510(k).
How long does a 510(k) take for product code OED?
Across 2 cleared submissions the average was 233 days from receipt to decision (median 233).
Which companies have the most OED clearances?
Statcorp Medical (1); Philips Medical Systems (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OED
- Run a recall and safety report across every OED manufacturer
- Watch product code OED 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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