FDA product code · Gastroenterology, Urology
KNTTubes, Gastrointestinal (And Accessories)
Product code KNT covers Tubes, Gastrointestinal (And Accessories), a Class II device regulated under 21 CFR 876.5980. FDA has cleared 650 devices in this code, 1 of them in the last 12 months. Median review time across the 650 most recent decisions is 94 days. openFDA lists 268 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 876.5980
- Review panel
- Gastroenterology, Urology
- Clearances
- 650
What is happening in KNT right now?
KNT (Tubes, Gastrointestinal (And Accessories)) has two findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2333-2026, Z-2334-2026, Z-2335-2026, Z-2336-2026, Z-2337-2026). The code is crowded, scoring 65 of 100 — 260 companies hold a clearance here and 1 arrived in the last 12 months (KNT:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2333-2026, Z-2334-2026, Z-2335-2026, Z-2336-2026, Z-2337-2026 |
| Crowding | Context | KNT:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in KNT?
FDA has cleared 650 devices under product code KNT since the 510(k) programme began in 1976, 1 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) | C.R. Bard, Inc. | |
| K250389 | XNY Disposable Gastric Calibration Tube | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | |
| K243228 | Flexi-Seal AIR (with ENFit Connector) | Convatec | |
| K242336 | hygh-tec Drainage II | Amb Medtec | |
| 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) | Tools For Surgery, LLC | |
| K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | |
| K241185 | CORGRIP* SR NG/NI Tube Retention System | Avanos Medical, Inc. | |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950) | Avanos Medical, Inc. | |
| K233591 | Stylus | Degania Silicone , Ltd. | |
| K241039 | ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) | Reshape Lifesciences |
How long does FDA review take for KNT?
The median FDA review time for KNT is 94 days, measured across the 650 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in KNT?
openFDA lists 268 recall records against product code KNT. A recall record covers one firm's corrective action and may span many device lots.
Z-2333-2026Open, ClassifiedAvanos Medical, Inc.
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Z-2334-2026Open, ClassifiedAvanos Medical, Inc.
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Z-2335-2026Open, ClassifiedAvanos Medical, Inc.
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Z-2336-2026Open, ClassifiedAvanos Medical, Inc.
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Z-2337-2026Open, ClassifiedAvanos Medical, Inc.
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets.
Showing the 5 most recently initiated of 268. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for KNT?
MAUDE holds 4,735 adverse-event reports naming product code KNT, 1,011 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in KNT unusual?
One month sits above KNT's own expected range: 1 May 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 156 | Insufficient history | No expected range — too little history | |
| 170 | Insufficient history | No expected range — too little history | |
| 198 | Insufficient history | No expected range — too little history | |
| 173 | Insufficient history | No expected range — too little history | |
| 138 | Insufficient history | No expected range — too little history | |
| 154 | Insufficient history | No expected range — too little history | |
| 160 | Insufficient history | No expected range — too little history | |
| 160 | Insufficient history | No expected range — too little history | |
| 96 | Insufficient history | No expected range — too little history | |
| 123 | Insufficient history | No expected range — too little history | |
| 164 | Insufficient history | No expected range — too little history | |
| 120 | Insufficient history | No expected range — too little history | |
| 112 | Insufficient history | No expected range — too little history | |
| 132 | Insufficient history | No expected range — too little history | |
| 101 | Insufficient history | No expected range — too little history | |
| 106 | Insufficient history | No expected range — too little history | |
| 107 | Insufficient history | No expected range — too little history | |
| 98 | Insufficient history | No expected range — too little history | |
| 120 | Insufficient history | No expected range — too little history | |
| 125 | Insufficient history | No expected range — too little history | |
| 115 | Insufficient history | No expected range — too little history | |
| 111 | 67–144 | Within expected (67–144) | |
| 89 | 60–127 | Within expected (60–127) | |
| 114 | 82–124 | Within expected (82–124) | |
| 119 | 89–130 | Within expected (89–130) | |
| 147 | 85–126 | Above expected (85–126) | |
| 126 | 88–156 | Within expected (88–156) | |
| 124 | 138–249 | Below expected (138–249) | |
| 106 | 85–176 | Within expected (85–176) | |
| 115 | 81–178 | Within expected (81–178) | |
| 111 | 77–172 | Within expected (77–172) | |
| 142 | 64–153 | Within expected (64–153) | |
| 135 | 80–183 | Within expected (80–183) | |
| 106 | 94–212 | Within expected (94–212) | |
| 158 | 62–173 | Within expected (62–173) | |
| 167 | 79–205 | Within expected (79–205) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in KNT.
What are the predicate devices in KNT?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in KNT?
Across the 650 most recent decisions, these applicants filed most often in KNT.
| Applicant | Recent clearances |
|---|---|
| Biosearch Medical Products, Inc. | 35 |
| Abbott Laboratories | 23 |
| Medical Innovations Corp. | 18 |
| Applied Medical Technology, Inc. | 16 |
| C.R. Bard, Inc. | 15 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch KNT
Get an email the morning anything changes in KNT — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Gastroenterology, Urology
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.