510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915634Substantially Equivalent

Fresenius Pd+ Exchange Device

Fresenius USA, Inc., Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915634 is the FDA 510(k) clearance record for FRESENIUS PD+ EXCHANGE DEVICE, a class I device, cleared for Fresenius USA, Inc. on under FDA product code EKX (Handpiece, Direct Drive, Ac-Powered). FDA records list 38 510(k) clearances for Fresenius USA, Inc., from to . As of , FDA records show no recalls naming K915634.

Clearance record

Decision date
Received
(562 days to decision)
Product code
EKX Handpiece, Direct Drive, Ac-Powered
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Fresenius USA, Inc. 4090 Pike Ln., Concord CA
510(k) summary
Statement
Third party review
No

Clearances, product code EKX

Trailing 12 months
1 clearance under product code EKX in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EKX, 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 20261
October 20260