Novartis Nutrition Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Novartis Nutrition Corp.” (first 1998, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 84 days. 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 | 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 4 | 4 |
| FPD | Tube, Feeding | 1 | 1 |
Review panels
Most recent Novartis Nutrition Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080340 | COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG | KNT | 2008-03-05 | 26 |
| K071191 | NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT | FPD | 2007-07-23 | 84 |
| K001916 | COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX | KNT | 2001-02-16 | 238 |
| K991668 | COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) | KNT | 1999-07-26 | 73 |
| K981323 | COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE | KNT | 1998-10-09 | 179 |
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-01-27.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Novartis Nutrition Corp.?
FDA lists 5 510(k) clearances under the applicant name “Novartis Nutrition Corp.” (first 1998, latest 2008), 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 Novartis Nutrition Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Novartis Nutrition Corp. is 84 days.
Which FDA product codes appear under Novartis Nutrition Corp.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 4); FPD (Tube, Feeding, 1).
Next steps
- See all 5 Novartis Nutrition Corp. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Novartis Nutrition Corp.'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.