Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Novartis Nutrition Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
238 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080340 | COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIE | Novartis Nutrition Corp. | 2008-03-05 | 26 | 0 |
| K071191 | NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUB | Novartis Nutrition Corp. | 2007-07-23 | 84 | 0 |
| K001916 | COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX | Novartis Nutrition Corp. | 2001-02-16 | 238 | 0 |
| K991668 | COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) | Novartis Nutrition Corp. | 1999-07-26 | 73 | 0 |
| K981323 | COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE | Novartis Nutrition Corp. | 1998-10-09 | 179 | 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