FDA product code MIA: Needle, Spinal, Short Term
MIA is the FDA product code for needle, spinal, short term. It is a Class II device, regulated under 21 CFR 868.5150 and reviewed by the Anesthesiology panel. FDA has cleared 10 510(k) submissions under MIA, from 10 different applicants. The average 510(k) review took 181 days (median 86).
Classification
| Field | Value |
|---|---|
| Device name | Needle, Spinal, Short Term |
| Device class | Class II |
| Regulation | 21 CFR 868.5150 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MIA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 269 |
Compare with all 510(k) review times · Search every MIA clearance
Top MIA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smiths Medical Asd, Inc. | 1 | 2018-06-14 |
| Epimed International, Inc. | 1 | 2005-08-22 |
| Sims Portex, Inc. | 1 | 1999-01-29 |
| Allegiance Healthcare Corp. | 1 | 1998-07-23 |
| Avid N.I.T., Inc. | 1 | 1997-08-01 |
5 more applicants have MIA clearances. See the full list in Caduvo.
Most recent MIA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172800 | Smiths Medical Asd, Inc. | Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors | 2018-06-14 | 269 |
| K051860 | Epimed International, Inc. | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 | 2005-08-22 | 45 |
| K983858 | Sims Portex, Inc. | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES | 1999-01-29 | 88 |
| K982269 | Allegiance Healthcare Corp. | CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA | 1998-07-23 | 24 |
| K971645 | Avid N.I.T., Inc. | REGANES SPINAL NEEDLE (VARIOUS) | 1997-08-01 | 88 |
Recalls for MIA devices
openFDA lists no recalls for product code MIA.
Frequently asked questions
What is FDA product code MIA?
MIA is the FDA product code for needle, spinal, short term. It is a Class II device, regulated under 21 CFR 868.5150 and reviewed by the Anesthesiology panel.
What device class is MIA?
Class II, regulation 21 CFR 868.5150. Typical premarket route: 510(k).
How long does a 510(k) take for product code MIA?
Across 10 cleared submissions the average was 181 days from receipt to decision (median 86).
Which companies have the most MIA clearances?
Smiths Medical Asd, Inc. (1); Epimed International, Inc. (1); Sims Portex, Inc. (1); Allegiance Healthcare Corp. (1); Avid N.I.T., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MIA
- Run a recall and safety report across every MIA manufacturer
- Watch product code MIA 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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