510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012266Substantially Equivalent

Sherwood 224, 324 Feeding Pump & K524 Intri-Flush, Model N7213iwc2

National Custom Ent., Inc., Burnsville MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012266 is the FDA 510(k) clearance record for SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2, a class II device, cleared for National Custom Ent., Inc. on under FDA product code MRZ (Accessories, Pump, Infusion). FDA records list 12 510(k) clearances for National Custom Ent., Inc., from to . As of , FDA records show no recalls naming K012266.

Clearance record

Decision date
Received
(56 days to decision)
Product code
MRZ Accessories, Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
National Custom Ent., Inc. 1133 E. Cliff Rd., Burnsville MN
510(k) summary
Statement
Third party review
No

Clearances, product code MRZ

Trailing 12 months

FDA records hold no clearances under product code MRZ in the trailing twelve months.

FDA records show no clearances under product code MRZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MRZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260