Product code KNT: 510(k) clearances and predicates
Product code KNT covers 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®. FDA lists 651 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
651 clearances on file under product code KNT. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 7 |
| 2023 | 5 |
| 2024 | 9 |
| 2025 | 4 |
| 2026 so far | 2 |
Recent clearances
Newest KNT clearances in the FDA index, with applicant and decision date:
- K261890, 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®, applicant Boehringer Laboratories, LLC, decided 2026-08-14. FDA record
- K253514, Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300), applicant C.R. Bard, Inc., decided 2026-07-10. FDA record
- K250389, XNY Disposable Gastric Calibration Tube, applicant Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd, decided 2025-04-10. FDA record
- K243228, Flexi-Seal AIR (with ENFit Connector), applicant Convatec, decided 2025-03-28. FDA record
- K242336, hygh-tec Drainage II, applicant Amb Medtec, decided 2025-01-17. FDA record
- K242901, ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40), applicant Tools For Surgery, LLC, decided 2025-01-10. FDA record
- K241169, Entarik NI Feeding Tube System, applicant Gravitas Medical, Inc., decided 2024-11-22. FDA record
- K241185, CORGRIP* SR NG/NI Tube Retention System, applicant Avanos Medical, Inc., decided 2024-10-25. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300), XNY Disposable Gastric Calibration Tube. Watch new KNT clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code KNT?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KNT clearances include 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®.
How many 510(k) clearances use product code KNT?
651 at the time this page was generated, from openFDA records.
How do I find a predicate device under KNT?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new KNT clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.