Sandoz Nutrition: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Sandoz Nutrition” (first 1986, latest 1997), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 162 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) | 11 | 11 |
| FPD | Tube, Feeding | 6 | 6 |
| LZH | Pump, Infusion, Enteral | 3 | 3 |
Review panels
Most recent Sandoz Nutrition 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K965087 | COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000) | KNT | 1997-03-18 | 89 |
| K961664 | COMPAT NASOJEJUNAL FEEDING TUBE | KNT | 1996-10-04 | 157 |
| K940555 | SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION | LZH | 1995-02-01 | 359 |
| K940556 | SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP | LZH | 1994-11-07 | 273 |
| K924308 | GASTROPORT II | KNT | 1993-07-29 | 337 |
| K923983 | PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT | KNT | 1993-04-06 | 242 |
| K915308 | PEG GASTROSTOMY TUBE KIT | FPD | 1993-03-12 | 477 |
| K920493 | PEG PREP TRAY | KNT | 1993-01-04 | 336 |
| K915439 | NASOGASTRIC FEEDING TUBE KITS | FPD | 1992-02-25 | 85 |
| K914492 | GASTROINTESTINAL TUBE AND ACCESSORIES | FPD | 1992-02-25 | 140 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sandoz Nutrition.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Sandoz Nutrition (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via LZH)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LZH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sandoz Nutrition?
FDA lists 20 510(k) clearances under the applicant name “Sandoz Nutrition” (first 1986, latest 1997), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sandoz Nutrition?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sandoz Nutrition is 162 days.
Which FDA product codes appear under Sandoz Nutrition?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 11); FPD (Tube, Feeding, 6); LZH (Pump, Infusion, Enteral, 3).
Next steps
- See all 20 Sandoz Nutrition clearances with predicates and recalls
- Run predicate analysis for product code KNT, Sandoz Nutrition'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.