FDA product code LBX: Pelvimeter, Internal
LBX is the FDA product code for pelvimeter, internal. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under LBX. The average 510(k) review took 36 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Pelvimeter, Internal |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LBX clearance
Top LBX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Imm Enterprises , Ltd. | 1 | 1983-12-27 |
Most recent LBX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K834173 | Imm Enterprises , Ltd. | OP-CON SURGICAL INSTRUMENTS #4 | 1983-12-27 | 36 |
Recalls for LBX devices
openFDA lists no recalls for product code LBX.
Frequently asked questions
What is FDA product code LBX?
LBX is the FDA product code for pelvimeter, internal. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is LBX?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
How long does a 510(k) take for product code LBX?
Across 1 cleared submissions the average was 36 days from receipt to decision (median 36).
Which companies have the most LBX clearances?
Imm Enterprises , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LBX
- Run a recall and safety report across every LBX manufacturer
- Watch product code LBX 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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