FDA product code OBI: Catheter, Pressure Monitoring, Cardiac
OBI is the FDA product code for catheter, pressure monitoring, cardiac. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under OBI. The average 510(k) review took 198 days (median 198). FDA has posted 1 recall for OBI devices.
Definition
To measure pressure within the cardiovascular system.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Pressure Monitoring, Cardiac |
| Device class | Class II |
| Regulation | 21 CFR 870.1200 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for OBI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 198 |
Compare with all 510(k) review times · Search every OBI clearance
Top OBI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acist Medical Systems, Inc. | 1 | 2019-09-13 |
Most recent OBI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190473 | Acist Medical Systems, Inc. | ACIST RXi System and Navvus II Catheter | 2019-09-13 | 198 |
Recalls for OBI devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-03-13.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0422 — Intensive cardiac rehabilitation; with or without continuous ecg monitoring with exercise, per session
- G0423 — Intensive cardiac rehabilitation; with or without continuous ecg monitoring; without exercise, per session
Frequently asked questions
What is FDA product code OBI?
OBI is the FDA product code for catheter, pressure monitoring, cardiac. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel.
What device class is OBI?
Class II, regulation 21 CFR 870.1200. Typical premarket route: 510(k).
How long does a 510(k) take for product code OBI?
Across 1 cleared submissions the average was 198 days from receipt to decision (median 198).
Which companies have the most OBI clearances?
Acist Medical Systems, Inc. (1).
Have OBI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-03-13.
Next steps
- Run an FDA pathway report with predicate devices for product code OBI
- Run a recall and safety report across every OBI manufacturer
- Watch product code OBI 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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