510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920063Substantially Equivalent

Disetronic Dolomat Pump

Disetronic Medical Systems, Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920063 is the FDA 510(k) clearance record for DISETRONIC DOLOMAT PUMP, a class I device, cleared for Disetronic Medical Systems on under FDA product code FRW (Scale, Patient). FDA records list 29 510(k) clearances for Disetronic Medical Systems, from to . As of , FDA records show no recalls naming K920063.

Clearance record

Decision date
Received
(574 days to decision)
Product code
FRW Scale, Patient
Regulation
21 CFR 880.2720
Device class
Class I
Review panel
General Hospital
Applicant
Disetronic Medical Systems 13911 Ridgedale Dr., Minnetonka MN
510(k) summary
Summary
Third party review
No

Clearances, product code FRW

Trailing 12 months

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

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