510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945964Substantially Equivalent - Subject to Tracking Reg.

Kangaroo(r) 524 Enteral Feeding Pump and Administration Sets

Sherwood Medical Co., St. Joseph MO / Traditional, Substantially Equivalent - Subject to Tracking Reg.
FDA source (opens on fda.gov)

K945964 is the FDA 510(k) clearance record for KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS, a class II device, cleared for Sherwood Medical Co. on under FDA product code LZH (Pump, Infusion, Enteral). FDA records list 191 510(k) clearances for Sherwood Medical Co., from to . As of , FDA records show no recalls naming K945964.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LZH Pump, Infusion, Enteral
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Sherwood Medical Co. Rosecrans Memorial Airport, St. Joseph MO
Third party review
No

Clearances, product code LZH

Trailing 12 months
1 clearance under product code LZH in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LZH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260