FDA product code MHC: Needle, Interosseous
MHC is the FDA product code for needle, interosseous. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under MHC, 1 in the last five years, from 2 different applicants. The average 510(k) review took 78 days (median 78).
Classification
| Field | Value |
|---|---|
| Device name | Needle, Interosseous |
| Device class | Class II |
| Regulation | 21 CFR 880.5570 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MHC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 127 |
| 2022 | 1 | 28 |
Compare with all 510(k) review times · Search every MHC clearance
Top MHC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bard Access Systems | 1 | 2022-11-10 |
| Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] | 1 | 2021-03-04 |
Most recent MHC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223198 | Bard Access Systems | BD Intraosseous Vascular Access System EMS Powered Driver (D001003) | 2022-11-10 | 28 |
| K203193 | Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] | BD Intraosseous Infusion System | 2021-03-04 | 127 |
Recalls for MHC devices
openFDA lists no recalls for product code MHC.
Frequently asked questions
What is FDA product code MHC?
MHC is the FDA product code for needle, interosseous. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel.
What device class is MHC?
Class II, regulation 21 CFR 880.5570. Typical premarket route: 510(k).
How long does a 510(k) take for product code MHC?
Across 2 cleared submissions the average was 78 days from receipt to decision (median 78).
Which companies have the most MHC clearances?
Bard Access Systems (1); Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MHC
- Run a recall and safety report across every MHC manufacturer
- Watch product code MHC 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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