510(k) · Cleared
ClearedCompat Mini-G Replacement Gastrostomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novartis Nutrition Corp. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Oct 9, 1998 as substantially equivalent to K885339 (Superior Healthcare Group, Inc., 1989) after a 179-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Oct 9, 1998
- Review
- 179 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K885339 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK885339 Flow Thru 16,18,20,22 FR Replace. Gastro Tube KitSuperior Healthcare Group, Inc. · 1989
- This deviceK981323 Compat Mini-G Replacement Gastrostomy TubeNovartis Nutrition Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K885339 | Flow Thru 16,18,20,22 FR Replace. Gastro Tube Kit | Superior Healthcare Group, Inc. | 1989 | — |
| 0 (this device) | K981323 | Compat Mini-G Replacement Gastrostomy Tube | Novartis Nutrition Corp. | 1998 | — |
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 KNT? 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 KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K885339 | Flow Thru 16,18,20,22 FR Replace. Gastro Tube KitSummary page 1…rition (Sandoz Nutrition)/Superior Healthcare Flow-Thru Replacement Balloon Gastrostomy Tube Kits. This line of replacement gastrostomy tubes is currently marketed under K885339. Description of the device that is the subject of this S10(K). This 510(k) is for the Novartis Nutrition COMPAT MINI-G Replacemen… | 1989 |
| † | K924308 | Gastroport II | 1993 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K885339.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, 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 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
The Novartis Nutrition COMPAT Mini-G Feeding Tube Kit provides for the delivery of enteral
formula through an externally minimized feeding tube. This replacement tube is used when there
exists an established, well healed and mature stoma tract communicating between the stomach and
external body surface. Externally minimized or low profile feeding devices are used to minimize
the exposure of the tube outside of the patient’s body and to provide an improved body image to
the patient by concealing the feeding device under the clothing.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981323 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981323: Compat Mini-G Replacement Gastrostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981323
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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