510(k) · Cleared
ClearedKnott NG Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Michael M. Knott, M.D. · FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Cleared on Nov 19, 1997 as substantially equivalent to K810156 (Sherwood Medical Co., 1981) after a 222-day review. Its family tree reaches back 1 generation to 1981. 8 later devices descend from it.
- Decided
- Nov 19, 1997
- Review
- 222 days
- Class
- Class II
- Product code
- FEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K810156 (1981). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK810156 Argyle Salem Sump TubeSherwood Medical Co. · 1981 · Recalled
- This deviceK971354 Knott NG TubeMichael M. Knott, M.D. · 1997
- Descendant · cites it directly · 7 of its ownK020005 Infant Feeding TubesPromedic, Inc. · 2002
- Descendant · 2 generations on · 6 of its ownK052903 Pediatric Feeding TubePromedic, Inc. · 2005
- Descendant · 3 generations on · 5 of its ownK072756 Non-IV Adapter for Infant NG TubePromedic, Inc. · 2007
- Descendant · 3 generations on · 4 of its ownK082710 Safechild Enteral Feeding Tube and Accessories and Feeding Tube…Neochild, LLC · 2009
- Descendant · 2 generations on · 2 of its ownK092628 Enteral Feeding Tube and Accessories, Feeding Tube Extension SetAlan Reid · 2010
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K020005Infant Feeding TubesPromedic, Inc. · 2002 · cites it directly7descendants
- K052903Pediatric Feeding TubePromedic, Inc. · 2005 · 2 generations on6descendants
- K072756Non-IV Adapter for Infant NG TubePromedic, Inc. · 2007 · 3 generations on5descendants
- K082710Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension SetNeochild, LLC · 2009 · 3 generations on4descendants
- K092628Enteral Feeding Tube and Accessories, Feeding Tube Extension SetAlan Reid · 2010 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810156 | Argyle Salem Sump Tube | Sherwood Medical Co. | 1981 | 3 |
| 0 (this device) | K971354 | Knott NG Tube | Michael M. Knott, M.D. | 1997 | — |
| +1 | K020005 | Infant Feeding Tubes | Promedic, Inc. | 2002 | — |
| +2 | K052903 | Pediatric Feeding Tube | Promedic, Inc. | 2005 | — |
| +3 | K072756 | Non-IV Adapter for Infant NG Tube | Promedic, Inc. | 2007 | — |
| +3 | K082710 | Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension Set | Neochild, LLC | 2009 | — |
| +2 | K092628 | Enteral Feeding Tube and Accessories, Feeding Tube Extension Set | Alan Reid | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2017 | 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 FEG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K810156 | Argyle Salem Sump TubeSummary page 1…ate Devices: page 1 of 2 November 19, 1997 Tel - 916-583-9371 Michael M. Knott, M.D. Knott nasogastric tube Nasogastric tube Nasogastric Sherwood - Salem Sump Tube - K810156 Device Description: The Knott NG tube is designed to permit withdrawal or introduction of fluids through a tube which is inser… | 1981 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020005 | Infant Feeding Tubes | 2002 | 7 |
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?
How does its category compare?
All FEG devicesFEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FEG
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · FEG
Too few FEG 510(k)s in any year since 2007 to give a median.
Recalls per year · FEG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FEG
46in 2025
MAUDE reports naming product code FEG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 36 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 27 |
| 2022 | 0 | — | 0 | 40 |
| 2023 | 0 | — | 10 | 33 |
| 2024 | 0 | — | 0 | 31 |
| 2025 | 0 | — | 2 | 46 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To permit withdrawal, introduction of fluids into the stomach or removal of stomach gas via a tube inserted through the nostril.
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/K971354 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971354: Knott NG Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971354
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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