Novo Nordisk, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Novo Nordisk, Inc.” (first 2005, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 118 days. Since 2017 the median was 116 days, against 166 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 251 |
| 2014 | 1 | 163 |
| 2015 | 1 | 121 |
| 2016 | 1 | 29 |
| 2017 | 0 | — |
| 2018 | 2 | 84 |
| 2019 | 0 | — |
| 2020 | 1 | 151 |
| 2021 | 1 | 142 |
| 2022 | 0 | — |
| 2023 | 1 | 116 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Novo Nordisk, Inc. took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 166 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 10 | 10 |
| FMF | Syringe, Piston | 4 | 4 |
Review panels
- General Hospital (14)
Most recent Novo Nordisk, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231255 | NovoFine® Plus | FMI | 2023-08-25 | 116 |
| K210258 | NovoFine | FMI | 2021-06-23 | 142 |
| K202005 | NovoFine Plus 32G Tip x 4 mm | FMI | 2020-12-19 | 151 |
| K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | FMF | 2018-12-17 | 104 |
| K173479 | NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) | FMI | 2018-01-17 | 65 |
| K162602 | NovoPen Echo | FMF | 2016-10-18 | 29 |
| K150874 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | FMF | 2015-07-31 | 121 |
| K133738 | NOVOFINE PLUS 32G 4 MM | FMI | 2014-05-21 | 163 |
| K123766 | NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN | FMF | 2013-08-15 | 251 |
| K093109 | NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') | FMI | 2010-06-18 | 260 |
4 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-07-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Novo Diagnostic Systems (2 510(k)s)
- Novo Nordisk Diagnostics, Ltd. (2 510(k)s)
- Novo Nordisk Pharmaceuticals, Inc. (2 510(k)s)
- Novo Nordisk A/S (1 510(k)s)
- Novo Norodisk Pharmaceuticals, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Novo Nordisk, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Novo Nordisk, Inc.” (first 2005, latest 2023), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Novo Nordisk, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Novo Nordisk, Inc. is 118 days. Since 2017: 116 days, versus 166 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Novo Nordisk, Inc.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 10); FMF (Syringe, Piston, 4).
Next steps
- See all 14 Novo Nordisk, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Novo Nordisk, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.