Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sandoz Nutrition · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
162 daysmedian FDA review time
359 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K965087 | COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000) | Sandoz Nutrition | 1997-03-18 | 89 | 0 |
| K961664 | COMPAT NASOJEJUNAL FEEDING TUBE | Sandoz Nutrition | 1996-10-04 | 157 | 0 |
| K940555 | SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATION | Sandoz Nutrition | 1995-02-01 | 359 | 1 |
| K940556 | SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP | Sandoz Nutrition | 1994-11-07 | 273 | 2 |
| K924308 | GASTROPORT II | Sandoz Nutrition | 1993-07-29 | 337 | 0 |
| K923983 | PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT | Sandoz Nutrition | 1993-04-06 | 242 | 0 |
| K915308 | PEG GASTROSTOMY TUBE KIT | Sandoz Nutrition | 1993-03-12 | 477 | 0 |
| K920493 | PEG PREP TRAY | Sandoz Nutrition | 1993-01-04 | 336 | 0 |
| K914492 | GASTROINTESTINAL TUBE AND ACCESSORIES | Sandoz Nutrition | 1992-02-25 | 140 | 0 |
| K915439 | NASOGASTRIC FEEDING TUBE KITS | Sandoz Nutrition | 1992-02-25 | 85 | 1 |
| K913407 | NASOJEJUNAL FEEDING TUBE W/GASTRIC DRAINAGE | Sandoz Nutrition | 1992-02-25 | 210 | 0 |
| K915438 | FEEDING TUBE Y-PORT CONNECTOR | Sandoz Nutrition | 1992-02-24 | 84 | 0 |
| K912575 | EXTERNAL GASTROSTOMY TUBE RETAINER | Sandoz Nutrition | 1991-11-21 | 162 | 0 |
| K893541 | VINYL BAG W/GRAVITY ADMINISTRATION SET | Sandoz Nutrition | 1989-10-17 | 162 | 0 |
| K893540 | VINYL BAG W/PUMP ADMINISTRATION SET | Sandoz Nutrition | 1989-10-17 | 162 | 0 |
| K891575 | COMPAT ENTERAL FEED PUMP 199235 & 199240 | Sandoz Nutrition | 1989-09-12 | 176 | 0 |
| K882682 | COMPAT ENTERAL DELIVERY SYSTEM | Sandoz Nutrition | 1988-10-28 | 122 | 0 |
| K882218 | COMPAT (R) ENTERAL DELIVERY SYSTEM | Sandoz Nutrition | 1988-09-13 | 110 | 0 |
| K855098 | COMPAT ENTERAL DELIVERY SYSTEMS | Sandoz Nutrition | 1986-04-08 | 106 | 0 |
| K855097 | COMPAT ENTERAL DELIVERY SYSTEMS | Sandoz Nutrition | 1986-04-08 | 106 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda