510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943733Substantially Equivalent - Subject to Tracking Reg.

Flexiflo Six Enteral Nutrition Pump

Abbott Mfg., Inc., Columbus OH / Traditional, Substantially Equivalent - Subject to Tracking Reg.
FDA source (opens on fda.gov)

K943733 is the FDA 510(k) clearance record for FLEXIFLO SIX ENTERAL NUTRITION PUMP, a class II device, cleared for Abbott Mfg., Inc. on under FDA product code LZH (Pump, Infusion, Enteral). FDA records list 14 510(k) clearances for Abbott Mfg., Inc., from to . As of , FDA records show no recalls naming K943733.

Clearance record

Decision date
Received
(132 days to decision)
Product code
LZH Pump, Infusion, Enteral
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Abbott Mfg., Inc. 1033 Kingsmill Pkwy., Columbus OH
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