Novo Nordisk a/S
Plainsboro, NJ, US
NOVO NORDISK A/S appears in FDA device records in Plainsboro, NJ. FDA records list 15 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Novo Nordisk a/S between 2001 and 2023. The busiest year on record is 2005, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2005 | 2 |
| 2006 | 1 |
| 2010 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231255 | NovoFine® Plus | FMI | Substantially Equivalent | |
| K210258 | NovoFine | FMI | Substantially Equivalent | |
| K202005 | NovoFine Plus 32G Tip x 4 mm | FMI | Substantially Equivalent | |
| K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | FMF | Substantially Equivalent | |
| K173479 | NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) | FMI | Substantially Equivalent | |
| K162602 | NovoPen Echo | FMF | Substantially Equivalent | |
| K150874 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | FMF | Substantially Equivalent | |
| K133738 | NOVOFINE PLUS 32G 4 MM | FMI | Substantially Equivalent | |
| K123766 | NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN | FMF | Substantially Equivalent | |
| K093109 | NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') | FMI | Substantially Equivalent | |
| K090111 | FLEXPEN NEEDLE | FMI | Substantially Equivalent | |
| K062500 | FLEXPEN NEEDLE | FMI | Substantially Equivalent | |
| K053470 | NOVOFINE 32G TIP | FMI | Substantially Equivalent | |
| K050106 | NOVOFINE AUTOCOVER 30G X 8MM | FMI | Substantially Equivalent | |
| K010359 | INNOVO | FMF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002807751 | 3002807751 | NOVO NORDISK A/S | Hallas Alle 1, Kalundborg Sjaelland 4400 DK | 2026 | |
| 9681821 | 3003131673 | NOVO NORDISK A/S | BRENNUM PARK, HILLEROED Hovedstaden DK-3400 DK | 2026 | |
| 2244771 | 2244771 | NOVO NORDISK INC. | 800 Scudders Mill Rd, Plainsboro, NJ 08536 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0206-2018 | Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo is a re-usable pen injector for single patient use by diabetics for the self injection of a desired dose of insulin. The pen injector uses Penfill 3 mL cartridge of NovoLog, 100 units/mL (Ux100) [insulin aspart (rDNA origin) injection] and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 increments. | A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain