510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K920637Substantially Equivalent

Prime Pca and Pca/continuous Systems

Prime Medical Products, Inc., Windermere FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920637 is the FDA 510(k) clearance record for PRIME PCA AND PCA/CONTINUOUS SYSTEMS, a class II device, cleared for Prime Medical Products, Inc. on under FDA product code MEA (Pump, Infusion, Pca). FDA records list 2 510(k) clearances for Prime Medical Products, Inc., from to . As of , FDA records show no recalls naming K920637.

Clearance record

Decision date
Received
(338 days to decision)
Product code
MEA Pump, Infusion, Pca
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Prime Medical Products, Inc. 12472 Park Ave., Windermere FL
510(k) summary
Summary
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