510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000842Substantially Equivalent

Cadd-Prizm Pcs II Model 6101 Ambulatory Infusion System

Sims Deltec, Inc., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000842 is the FDA 510(k) clearance record for CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM, a class II device, cleared for Sims Deltec, Inc. on under FDA product code FRN (Pump, Infusion). FDA records list 32 510(k) clearances for Sims Deltec, Inc., from to . As of , FDA records show 2 recalls naming K000842.

Clearance record

Decision date
Received
(85 days to decision)
Product code
FRN Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Sims Deltec, Inc. 1265 Grey Fox Rd., St. Paul MN
510(k) summary
Summary
Third party review
No

Clearances, product code FRN

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