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510(k) K100700

MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES by Benlan, Inc. — Product Code FPD

K100700 is an FDA 510(k) premarket notification submitted by Benlan, Inc. for the device "MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on December 13, 2010. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Benlan, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2010
Date Received
March 12, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Feeding
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Benlan, Inc.

  • K131183 — MED-RX ORAL/ENTERAL SYRINGE (June 3, 2014)
  • K120375 — MED-RX PATIENT DELIVERY SET (June 28, 2012)
  • K112799 — MED-RX EXTENSION SET WITH T-CONNECTOR (December 23, 2011)
  • K102073 — MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS (November 8, 2010)
  • K010607 — MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 (November 28, 2001)
  • K990777 — MED-RX EXTENSION SETS (August 25, 1999)

Other clearances for product code FPD

  • K243361 — Nutrifit (December 19, 2024)
  • K180236 — VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (January 18, 2019)
  • K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE (October 23, 2013)
  • K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE (March 6, 2013)
  • K121105 — NUTRISAFE 2 FEEDING TUBE (December 18, 2012)
  • K100163 — NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX (October 13, 2011)
  • K110853 — VR MEDICAL ENTERAL ORAL SYRINGE (May 13, 2011)
  • K101214 — GUARDIAN CONNECTION (July 23, 2010)
  • K100099 — ORAL/ENTERAL SYRINGES (June 14, 2010)
  • K100526 — AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE (April 22, 2010)

FDA data resources