MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES— 510(k) K100700

Clearance details

Applicant

Benlan, Inc.

Product code

Code FPD

Device class

Class 2

Regulation

21 CFR 876.5980

Advisory panel

Gastroenterology, Urology

Date received

2010-03-12

Decision date

2010-12-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Oakville, CA

• K243361 — Nutrifit2024-12-19
• K180236 — VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)2019-01-18
• K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE2013-10-23
• K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE2013-03-06
• K121105 — NUTRISAFE 2 FEEDING TUBE2012-12-18

• K131183 — MED-RX ORAL/ENTERAL SYRINGE2014-06-03
• K120375 — MED-RX PATIENT DELIVERY SET2012-06-28
• K112799 — MED-RX EXTENSION SET WITH T-CONNECTOR2011-12-23
• K102073 — MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS2010-11-08
• K010607 — MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-40012001-11-28

Death

6

Other

1

Total

7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2293-2019 — DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane c) REF 54-2480R, 8 FR x 24" Polyurethane d) REF 54-3680R, 8 FR x 36" Polyurethane Product Usage: Feeding tubeClass II·Terminated·DeRoyal Industries Inc·20190722
• Z-2281-2019 — MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680RClass II·Terminated·Canadian Hospital Specialties·20190716
• Z-0746-2019 — DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physicianClass II·Terminated·DeRoyal Industries Inc·20181217
• Z-0725-2019 — MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician.Class II·Terminated·Canadian Hospital Specialties·20181201
• Z-2440-2018 — MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 10/case, Sterile, RX. The firm name on the label is chs, Oakville, ON, Canada.Class II·Terminated·Canadian Hospital Specialties·20180611
• Z-0595-2016 — MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, CanadaClass II·Terminated·Benlan, Inc.·20151211

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100700.