510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834585Substantially Equivalent

Celltrak-B

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

K834585 is the FDA 510(k) clearance record for CELLTRAK-B, a class II device, cleared for R&D Systems, Inc. on under FDA product code FRZ (Device, Patient Transfer, Powered). FDA records list 79 510(k) clearances for R&D Systems, Inc., from to . As of , FDA records show no recalls naming K834585.

Clearance record

Decision date
Received
(125 days to decision)
Product code
FRZ Device, Patient Transfer, Powered
Regulation
21 CFR 880.6775
Device class
Class II
Review panel
General Hospital
Applicant
R&D Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FRZ

Trailing 12 months

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

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