Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KNT — Predicate Candidate Screening
650 FDA 510(k) clearances under this product code; the 50 most recent screened below.
95 daysmedian FDA review time
337 days90th percentile
650clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 Fre | C.R. Bard, Inc. | 2026-07-10 | 246 | 0 |
| K250389 | XNY Disposable Gastric Calibration Tube | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2025-04-10 | 58 | 0 |
| K243228 | Flexi-Seal AIR (with ENFit Connector) | Convatec | 2025-03-28 | 171 | 0 |
| K242336 | hygh-tec Drainage II | Amb Medtec | 2025-01-17 | 163 | 0 |
| K242901 | ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr | Tools For Surgery, LLC | 2025-01-10 | 109 | 0 |
| K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | 2024-11-22 | 210 | 0 |
| K241185 | CORGRIP* SR NG/NI Tube Retention System | Avanos Medical, Inc. | 2024-10-25 | 179 | 0 |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950) | Avanos Medical, Inc. | 2024-06-06 | 58 | 0 |
| K233591 | Stylus | Degania Silicone , Ltd. | 2024-05-31 | 205 | 0 |
| K241039 | ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape | Reshape Lifesciences | 2024-05-16 | 30 | 0 |
| K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | Boehringer Laboratories, LLC | 2024-05-06 | 138 | 0 |
| K240039 | Enteral Feeding Sets | Hangzhou Primecare Medical Co., Ltd. | 2024-04-17 | 103 | 0 |
| K240069 | Endolumik Gastric Calibration Tube M Series (EGCT36M); Endol | Endolumik | 2024-02-08 | 30 | 0 |
| K234145 | ViSiGi 3D Gastric Sizing Tube | Boehringer Laboratories | 2024-01-26 | 28 | 0 |
| K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Applied Medical Technology, Inc. | 2023-12-18 | 453 | 0 |
| K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | Gravitas Medical, Inc. | 2023-03-24 | 58 | 0 |
| K222880 | Endolumik Fluorescence Guided Gastric Calibration Tube (FG B | Endolumik, Inc. | 2023-03-03 | 162 | 0 |
| K230131 | ReShape Calibration Tubes | Reshape Lifesciences | 2023-02-15 | 29 | 0 |
| K221400 | hygh-tec drainage | Creative Balloons GmbH | 2023-02-09 | 269 | 0 |
| K222085 | Standard Tapered Bougie, 38 Fr. | Standard Bariatrics, Inc. | 2022-10-31 | 108 | 0 |
| K212316 | DoubleChek DC-1001 | Nasogastric Feeding Solutions, Ltd. | 2022-09-30 | 431 | 0 |
| K221898 | Gastrointestinal Boundary Identifier (GIBI HD) | Reshape Lifesciences | 2022-07-28 | 28 | 0 |
| K212407 | Gastric Lightguide (GLG) | Naser Dib Gabinet Lekarksi Nasmed | 2022-07-26 | 357 | 0 |
| K220455 | Lap-Band System Calibration Tube | Reshape Lifesciences | 2022-06-07 | 110 | 0 |
| K220218 | Siren SGT | Tools For Surgery, LLC | 2022-05-18 | 112 | 0 |
| K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS) | Avanos Medical, Inc. | 2022-04-22 | 52 | 0 |
| K212444 | Qora Stool Management Kit | Cm Technologies, Inc. | 2021-11-17 | 104 | 0 |
| K212728 | Standard Bougie, 38 Fr. and Hand Pump | Standard Bariatrics | 2021-09-23 | 27 | 0 |
| K210437 | Standard Bougie, 38 Fr. | Standard Bariatrics | 2021-06-29 | 137 | 0 |
| K211072 | Safety Trocar Cannula | Boston Scientific Corporation | 2021-04-27 | 15 | 0 |
| K202748 | Enteral Feeding Catheter | Medcaptain Life Science Co., Ltd. | 2021-04-09 | 200 | 0 |
| K203133 | ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube | Envizion Medical , Ltd. | 2021-03-24 | 156 | 0 |
| K200646 | TubeClear System | Actuated Medical, Inc. | 2020-12-04 | 267 | 0 |
| K202539 | Nutriglide(TM) Nasal Feeding Tube | Applied Medical Technology, Inc. | 2020-10-29 | 57 | 6 |
| K201322 | Entuit Nasal Jejunal Feeding Tube | Wilson-Cook Medical, Inc. | 2020-06-17 | 30 | 0 |
| K191885 | Standard Bougie | Standard Bariatrics | 2020-04-08 | 268 | 0 |
| K193325 | Avantgarde Faecal Management Systems, Avantgarde Faecal Mana | Prosys International, Ltd. | 2020-03-13 | 102 | 0 |
| K190977 | Navina Smart System, Navina Classic System | Dentsply Sirona | 2019-11-22 | 221 | 0 |
| K190084 | McLean-Ring Enteral Feeding Tube Set | Cook Incorporated | 2019-10-11 | 267 | 0 |
| K191387 | ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feed | Envizion Medical , Ltd. | 2019-06-14 | 21 | 0 |
| K191340 | CORTRAK* 2 Equilateral Enteral Access System | Avanos Medical, Inc. | 2019-06-04 | 15 | 1 |
| K183336 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | 2019-05-29 | 177 | 0 |
| K183577 | Medline Quick-Clear Wand | Medline Industries, Inc. | 2019-05-04 | 134 | 0 |
| K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit | Convatec Limited | 2019-04-30 | 96 | 0 |
| K183508 | Micro Transgastric-Jejunal Feeding Device | Applied Medical Technology, Inc. | 2019-03-29 | 101 | 0 |
| K182804 | Traditional Length GJ Feeding Device | Applied Medical Technology, Inc. | 2019-03-01 | 150 | 0 |
| K182915 | ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tub | Envizion Medical , Ltd. | 2019-02-13 | 118 | 0 |
| K182248 | Aspire Venting Tube | Aspire Bariatrics, Inc. | 2018-11-13 | 85 | 0 |
| K180605 | GastroFlush | Bionix Development Corporation | 2018-10-24 | 231 | 0 |
| K180622 | Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port | Covidien | 2018-10-23 | 228 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda