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FDA product code · Gastroenterology, Urology · Class 2

KNT: Tubes, Gastrointestinal (And Accessories)

KNT is FDA's product code for "Tubes, Gastrointestinal (And Accessories)": a Class 2 device classified under 21 CFR 876.5980, reviewed by the Gastroenterology, Urology panel.

510(k) review time for KNT

Across 55 510(k) clearances under KNT decided from 2018-01-01 to 2026-10-06, the median was 113 days from FDA receipt to decision. Half took between 58 and 203 days, and 80% were decided within 222 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, KNT, decisions 2018-01-01 to 2026-10-06 (n = 55)
Fastest15
25th percentile58
Median113
75th percentile203
80th percentile222
90th percentile268
Slowest453
Median days by decision year, KNT (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20181497
201912610
20201025
20211216
20221107
20231625
20241039

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

KNT in the public FDA record

Records naming KNT, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years651
Device recalls268
Establishment listings686
GUDID device identifiers8,280

Counts of records, not of devices or events. Adverse event reports for KNT are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite KNT

4 FDA recognized consensus standards cite KNT, among them ISO 80369-3 First Edition 2016-07-01; ISO 18250-3 First edition 2018-06; ISO 20695 First edition 2020-03. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 5-123 ISO 80369-3 First Edition 2016-07-01 — Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
  • 5-139 ISO 18250-3 First edition 2018-06 — Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
  • 9-138 ISO 20695 First edition 2020-03 — Enteral feeding systems - Design and testing
  • 9-31 ANSI AAMI ID54:1996/(R)2012 — Enteral feeding set adapters and connectors

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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