510(k) · Cleared
ClearedNGT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Innovative Products · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jul 8, 2003 as substantially equivalent to K960176 (C.R. Bard, Inc., 1996) and 2 other predicates after a 340-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jul 8, 2003
- Review
- 340 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K914887 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK914887 Esophageal Stethoscope W/Temp Sensor/Gastric SuctMallinckrodt Medical · 1992
- This deviceK022558 NGTMedical Innovative Products · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914887 | Esophageal Stethoscope W/Temp Sensor/Gastric Suct | Mallinckrodt Medical | 1992 | — |
| 0 (this device) | K022558 | NGT | Medical Innovative Products | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
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? (3)
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 |
|---|---|---|---|
| * | K960176 | Davol Nasogastric Sump Tube W/Prevent FilterSummary page 1…mon/Usual Name: Nasogastric Tube 3. Identification of Predicate or Legally Marketed Device 0 Bard Nasogastric Sump Tube manufactured by C.R. Bard cleared under K960176 0 Argyle Salem Sump Tube manufactured by Sherwood Medical cleared under K93578'1 0 Mon-a-therm Esophageal Stethosco… | 1996 |
| * | K935781 | Argyle Salem Sump Tube Anti-Reflux Valve Insertion Tray | 1995 |
| * | K914887 | Esophageal Stethoscope W/Temp Sensor/Gastric SuctSummary page 1…ctured by Sherwood Medical cleared under K93578'1 0 Mon-a-therm Esophageal Stethoscope with temperature sensor manufactured by Mallinckrodt cleared under K914887 4. Device Description The NGT Nasogastric Tube is made of a plastic material, contains three lumens, a main suction… | 1992 |
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?
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K960176.
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 NGT is intended for gastric decompression, gastric lavage, gastric suction, administration of nutritional supplements and medication, and to monitor core temperature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022558 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022558: NGT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022558
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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