Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PIF — Predicate Candidate Screening
50 FDA 510(k) clearances under this product code; the 50 most recent screened below.
161 daysmedian FDA review time
283 days90th percentile
50clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | Degania Silicone , Ltd. | 2026-03-20 | 87 | 0 |
| K242917 | Enteral Drainage System, Enteral Medicine straw | HMC Premedical S.p.A. | 2025-06-18 | 267 | 0 |
| K250481 | Extension Feeding Set with ENFit™ Connectors | SKY Medical, a.s. | 2025-04-18 | 58 | 0 |
| K240052 | Disposable Enteral Feeding Sets | Beijing L&Z Medical Technology Development Co., Ltd. | 2024-07-03 | 177 | 0 |
| K233034 | Mobility+ Enteral Feeding System OTC | Rockfield Medical | 2024-04-12 | 200 | 0 |
| K230326 | ENFit to ENFit Extension Sets | Vesco Medical | 2023-11-02 | 269 | 0 |
| K232046 | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2023-10-06 | 88 | 0 |
| K222773 | Feeding Tube | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-17 | 337 | 0 |
| K223683 | EnteraLoc Flow | Vonco Products | 2023-07-10 | 214 | 0 |
| K222678 | Mobility+ Enteral Feeding System | Rockfield Medical | 2022-10-27 | 51 | 0 |
| K213258 | Nasogastric Feeding Tubes - ENFit Port - PVC | Cair Lgl | 2022-06-09 | 252 | 0 |
| K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Conne | Cardinalhealth | 2022-05-19 | 233 | 0 |
| K213356 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | 2022-01-20 | 100 | 0 |
| K210854 | Enteral Feeding Set | Kb Medical (Group), Inc. | 2021-11-16 | 238 | 0 |
| K210598 | Pediatric Nasogastric Feeding Tubes - Single ENFit Port | Cair Lgl | 2021-11-02 | 246 | 0 |
| K203633 | Enteral Extension Sets | GBUK Group, Ltd. | 2021-08-19 | 251 | 0 |
| K210971 | EnteraLoc Flow | Vonco Products | 2021-08-18 | 140 | 0 |
| K201741 | Gabriel 3 Way EnFit Valve | Syncro Medical Innovations, Inc. | 2020-11-05 | 133 | 0 |
| K202357 | Nutricare Clear-ISOSAF Nasogastric Feeding Tube | Three Circles Consulting Limited | 2020-10-01 | 43 | 0 |
| K192991 | Vesco Medical Extension Feeding Set | Vesco Medical, LLC | 2020-08-03 | 283 | 0 |
| K200082 | BD Univia RightFit Enteral Extension Sets and Transitional A | Mps Medical, Inc. | 2020-07-30 | 197 | 0 |
| K191759 | Medline Quick Switch Valve with ENFit Connector | Medline Industries, Inc. | 2019-12-04 | 156 | 0 |
| K191784 | Gabriel Feeding Tube with Balloon, and EnFit Connector | Syncro Medical Innovations, Inc. | 2019-11-15 | 135 | 0 |
| K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | 2019-11-07 | 212 | 1 |
| K190414 | Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV | Moss Tubes, Inc. | 2019-06-14 | 113 | 0 |
| K190310 | U Deliver Bolink ENFit Enteral Feeding Sets | U Deliver Medical, LLC | 2019-05-31 | 108 | 0 |
| K181787 | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feedi | Cedic S.R.L. | 2019-04-25 | 294 | 0 |
| K190327 | ENConnect 40 mm Screw Cap to ENPlus Adapter | Cedic S.R.L. | 2019-04-09 | 55 | 0 |
| K180708 | Entuit LP Gastrostomy BR Low Profile Balloon Retention Feedi | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2018-10-18 | 213 | 0 |
| K181276 | CONOD Enteral Feeding Sets | Conod Medical Co., Limited | 2018-07-12 | 59 | 0 |
| K170162 | Vesco Medical Nasoenteric Feeding Tubes | Vesco Medical, LLC | 2017-09-26 | 251 | 0 |
| K170555 | U Deliver Bolink ENFit Enteral Feeding Sets | U Deliver Medical, LLC | 2017-08-17 | 174 | 0 |
| K171347 | Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFi | Xeridiem Medical Devices | 2017-06-06 | 29 | 0 |
| K163586 | Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with | Trovrx, Inc. Dba Trovita Health Science | 2017-03-17 | 87 | 0 |
| K153688 | Edi Catheter ENFit | Maquet Critical Care AB | 2017-03-02 | 435 | 0 |
| K160642 | Medline ENFit Syringe | Medline Industries, Inc. | 2016-11-29 | 267 | 0 |
| K161003 | EndoVive One Step Button Low Profile Initial Placement PEG K | Boston Scientific Corporation | 2016-06-17 | 67 | 1 |
| K151503 | NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE | Gbuk Enteral Limited | 2016-04-05 | 306 | 0 |
| K150711 | Salem Sump Dual Lumen Stomach Tube with Multi-functional Por | Covidien | 2015-10-08 | 203 | 0 |
| K150084 | Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane | Covidien | 2015-07-13 | 179 | 0 |
| K150679 | EndoVive Initial Placement Standard PEG Kit with ENFit Conne | Boston Scientific Corp | 2015-05-29 | 73 | 3 |
| K150286 | Medline Enteral Feeding Sets | Medline Industries, Inc. | 2015-04-27 | 81 | 0 |
| K143018 | Kangaroo Enteral Feeding Tube Extension Set with ENFit Small | Covidien | 2015-04-02 | 164 | 0 |
| K142989 | Mini ONE Enteral Extension Set | Applied Medical Technology, Inc. | 2015-01-29 | 105 | 1 |
| K142539 | EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enter | Zevex, Inc. | 2015-01-08 | 121 | 0 |
| K142075 | BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY F | Xeridiem (Formerly Mri) | 2015-01-08 | 161 | 0 |
| K142297 | Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Ext | Xeridiem (Formerly Mri) | 2015-01-08 | 143 | 0 |
| K142012 | FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT E | Corpak Medsystems | 2014-11-20 | 119 | 0 |
| K141753 | AQUARIUS NASAL FEEDING TUBE | Degania Silicone , Ltd. | 2014-10-16 | 108 | 0 |
| K140947 | COMPAT ENTERAL DELIVERY PUMP SETS | Nestle Healthcare Nutrition, Inc. | 2014-09-04 | 143 | 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