Smith & Nephew, Mpl Division: FDA clearances and approvals
Smith & Nephew, Mpl Division has 9 FDA 510(k) clearances (first 1976, latest 1984), across 6 product codes in 3 review panels. Median 510(k) review time: 41 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZM | Needle, Dental | 2 | 2 |
| EJI | Syringe, Cartridge | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
| EIC | Syringe, Periodontic, Endodontic, Irrigating | 1 | 1 |
| FPB | Filter, Infusion Line | 1 | 1 |
Review panels
- Dental (5)
- General Hospital (3)
- Anesthesiology (1)
Most recent Smith & Nephew, Mpl Division 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843314 | MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE | EJI | 1984-09-27 | 34 |
| K841280 | SOLOPAK BRAND FILTER NEEDLE W/5 MICRO | FPB | 1984-05-21 | 54 |
| K840237 | MAX-I-PROBE PERIODONTAL ENDODONTIC PROB | EIC | 1984-04-05 | 76 |
| K833304 | HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST | DZM | 1984-03-30 | 189 |
| K832126 | MICRO Z DISPOS. SPINAL ANESTH. NEEDLE | BSP | 1983-08-12 | 42 |
| K831765 | HERAPIN LOCK FLUSH SOLUTION USE KIT | FMI | 1983-07-12 | 41 |
| K830524 | HENKE JECT PRESSURE SYRINGE | EJI | 1983-03-24 | 35 |
| K830242 | MICRO 2 HYPODERMIC NEEDLES | FMI | 1983-02-15 | 21 |
| K761206 | INTEROSSEOUS NEEDLE | DZM | 1976-12-13 | 6 |
Recalls
openFDA lists no recalls under a recalling firm named Smith & Nephew, Mpl Division.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Smith & Nephew, Mpl Division have?
Smith & Nephew, Mpl Division has 9 FDA 510(k) clearances (first 1976, latest 1984), across 6 product codes in 3 review panels.
How long does FDA take to clear Smith & Nephew, Mpl Division's 510(k)s?
The median time from FDA receipt to decision across Smith & Nephew, Mpl Division's cleared 510(k)s is 41 days.
What devices does Smith & Nephew, Mpl Division make?
Its most frequent FDA product codes are DZM (Needle, Dental, 2); EJI (Syringe, Cartridge, 2); FMI (Needle, Hypodermic, Single Lumen, 2).
Has Smith & Nephew, Mpl Division had device recalls?
openFDA lists no recalls under a recalling firm name matching Smith & Nephew, Mpl Division. Related entities may recall under other names.
Next steps
- See all 9 Smith & Nephew, Mpl Division clearances with predicates and recalls
- Run predicate analysis for product code DZM, Smith & Nephew, Mpl Division's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.