510(k) · Cleared
ClearedNovartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novartis Nutrition Corp. · FPD Tube, Feeding
Cleared on Jul 23, 2007 as substantially equivalent to K965087 (Sandoz Nutrition, 1997) after an 84-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Jul 23, 2007
- Review
- 84 days
- Class
- Class II
- Product code
- FPD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K853353 (1985). No later device cites it as a predicate yet.
- Root · 2 generations backK853353 88000 Gastrostomy-Jejunal Feeding Tube KitSuperior Healthcare Group, Inc. · 1985
- 1 generation backK965087 Compat Gastrostomy/Jejunostomy Feeding Tube Kit (088000)Sandoz Nutrition · 1997
- This deviceK071191 Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube KitNovartis Nutrition Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K853353 | 88000 Gastrostomy-Jejunal Feeding Tube Kit | Superior Healthcare Group, Inc. | 1985 | — |
| −1 | K965087 | Compat Gastrostomy/Jejunostomy Feeding Tube Kit (088000) | Sandoz Nutrition | 1997 | — |
| 0 (this device) | K071191 | Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube Kit | Novartis Nutrition Corp. | 2007 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FPD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FPD device
- #1 K243361 Nutrifitscore 8.8 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K965087 | Compat Gastrostomy/Jejunostomy Feeding Tube Kit (088000)Summary page 1…Product Code KNT Predicate Device: Novartis Item 088000, COMPAT® Surgical Gastrojejunostomy Feeding Tube Kit, (K965087) Manufacturer: Novartis Nutrition Corporation 1541 Park Place Blvd… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All FPD devicesFPD Tube, Feeding: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FPD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FPD
118in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPD
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPD
10in 2025
MAUDE reports naming product code FPD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 19 |
| 2008 | 4 | 76 | 0 | 24 |
| 2009 | 4 | 69 | 0 | 40 |
| 2010 | 4 | 118 | 0 | 21 |
| 2011 | 2 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 32 |
| 2013 | 2 | — | 0 | 38 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 1 | 55 |
| 2016 | 0 | — | 0 | 102 |
| 2017 | 0 | — | 0 | 34 |
| 2018 | 0 | — | 3 | 30 |
| 2019 | 1 | — | 1 | 19 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 55 |
| 2024 | 1 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The COMPAT® Surgical Gastrostomy/Jejunostomy Feeding Tube Kit provides for the
delivery of enteral formula through a surgically placed Gastrostomy/Jejunostomy feeding
tube. Jejunal feeding is used when patients require feeding past the stomach directly
into the jejunum. This method is used to enhance the absorption of nutrients and
minimize the risks of gastric feeding including gastric reflux and aspiration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071191 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071191: Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071191
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026