FDA product code KNT: Tubes, Gastrointestinal (And Accessories)
KNT is the FDA product code for tubes, gastrointestinal (and accessories). It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 651 510(k) submissions under KNT, 27 in the last five years, from 275 different applicants. The average 510(k) review took 152 days (median 94); 131 days on average over the last three years. FDA has posted 268 recalls for KNT devices, 53 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tubes, Gastrointestinal (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for KNT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 265 |
| 2018 | 7 | 163 |
| 2019 | 10 | 130 |
| 2020 | 5 | 145 |
| 2021 | 6 | 106 |
| 2022 | 7 | 171 |
| 2023 | 5 | 194 |
| 2024 | 9 | 109 |
| 2025 | 4 | 125 |
| 2026 | 2 | 158 |
Compare with all 510(k) review times · Search every KNT clearance
Top KNT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biosearch Medical Products, Inc. | 35 | 1994-09-08 |
| Abbott Laboratories | 23 | 2012-04-20 |
| Medical Innovations Corp. | 18 | 1995-04-19 |
| Applied Medical Technology, Inc. | 16 | 2023-12-18 |
| C.R. Bard, Inc. | 15 | 2026-07-10 |
270 more applicants have KNT clearances. See the full list in Caduvo.
Most recent KNT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261890 | Boehringer Laboratories, LLC | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D® | 2026-08-14 | 70 |
| K253514 | C.R. Bard, Inc. | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) | 2026-07-10 | 246 |
| K250389 | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | XNY Disposable Gastric Calibration Tube | 2025-04-10 | 58 |
| K243228 | Convatec | Flexi-Seal AIR (with ENFit Connector) | 2025-03-28 | 171 |
| K242336 | Amb Medtec | hygh-tec Drainage II | 2025-01-17 | 163 |
Recalls for KNT devices
268 product recalls in 54 recall events; 53 initiated in the last five years and 40 still open. Most recent: 2026-04-30.
| Year | Recalls |
|---|---|
| 2017 | 12 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 9 |
| 2025 | 19 |
| 2026 | 20 |
Frequently asked questions
What is FDA product code KNT?
KNT is the FDA product code for tubes, gastrointestinal (and accessories). It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is KNT?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code KNT?
Across 651 cleared submissions the average was 152 days from receipt to decision (median 94).
Which companies have the most KNT clearances?
Biosearch Medical Products, Inc. (35); Abbott Laboratories (23); Medical Innovations Corp. (18); Applied Medical Technology, Inc. (16); C.R. Bard, Inc. (15).
Have KNT devices been recalled?
Yes: 268 product recalls across 54 recall events; the most recent began 2026-04-30.
Next steps
- Run an FDA pathway report with predicate devices for product code KNT
- Run a recall and safety report across every KNT manufacturer
- Watch product code KNT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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