510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003534Substantially Equivalent

Pentra 5D

R & D Systems, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003534 is the FDA 510(k) clearance record for PENTRA 5D, a class II device, cleared for R&D Systems, Inc. on under FDA product code JPK (Mixture, Hematology Quality Control). FDA records list 79 510(k) clearances for R&D Systems, Inc., from to . As of , FDA records show no recalls naming K003534.

Clearance record

Decision date
Received
(15 days to decision)
Product code
JPK Mixture, Hematology Quality Control
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
R&D Systems, Inc. 614 Mckinley Pl. NE, Minneapolis MN
510(k) summary
Summary
Third party review
No

Clearances, product code JPK

Trailing 12 months

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

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