510(k) K100700 ยท FPD Tube, Feeding
MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES
| Applicant | Benlan, Inc., Oakville, CA |
| Decision | Substantially Equivalent, Dec 13, 2010 |
| Received | Mar 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100700
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2019 | DeRoyal Industries Inc 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" Polyurethan Terminated |
FPD | None listed |
| Jul 16, 2019 | Canadian Hospital Specialties 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 Terminated |
FPD | None listed |
| Dec 17, 2018 | DeRoyal Industries Inc 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 Terminated |
FPD | None listed |
| Dec 1, 2018 | Canadian Hospital Specialties 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 tu Terminated |
FPD | None listed |
| Jul 13, 2018 | Canadian Hospital Specialties 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 Terminated |
FPD | None listed |
| Dec 11, 2015 | Benlan, Inc. 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, Canada Terminated |
FPD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.