FDA product code MHD: Pump, Infusion, Gallstone Dissolution
MHD is the FDA product code for pump, infusion, gallstone dissolution. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under MHD. The average 510(k) review took 19 days (median 19).
Classification
| Field | Value |
|---|---|
| Device name | Pump, Infusion, Gallstone Dissolution |
| Device class | Class II |
| Regulation | 21 CFR 880.5725 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MHD clearance
Top MHD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Agilent Technologies, Inc. | 1 | 1999-12-06 |
Most recent MHD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K993907 | Agilent Technologies, Inc. | VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22 | 1999-12-06 | 19 |
Recalls for MHD devices
openFDA lists no recalls for product code MHD.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- A4220 — Refill kit for implantable infusion pump
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement
Frequently asked questions
What is FDA product code MHD?
MHD is the FDA product code for pump, infusion, gallstone dissolution. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel.
What device class is MHD?
Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code MHD?
Across 1 cleared submissions the average was 19 days from receipt to decision (median 19).
Which companies have the most MHD clearances?
Agilent Technologies, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MHD
- Run a recall and safety report across every MHD manufacturer
- Watch product code MHD 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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