510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162165Substantially Equivalent

ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump

Summit Medical Products, Inc., Sandy UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162165 is the FDA 510(k) clearance record for ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump, a class II device, cleared for Summit Medical Products, Inc. on under FDA product code MEA (Pump, Infusion, Pca). FDA records list 4 510(k) clearances for Summit Medical Products, Inc., from to . As of , FDA records show 5 recalls naming K162165.

Clearance record

Decision date
Received
(391 days to decision)
Product code
MEA Pump, Infusion, Pca
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Summit Medical Products, Inc. 504 W. 8360 S., Sandy UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MEA

Trailing 12 months

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

FDA records show no clearances under product code MEA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MEA, 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