510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K820166Substantially Equivalent

Adaptation of Kantron 40 Cc. Pdliab

Kontron Instruments, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820166 is the FDA 510(k) clearance record for ADAPTATION OF KANTRON 40 CC. PDLIAB, a class II device, cleared for Kontron Instruments, Inc. on under FDA product code DSP (System, Balloon, Intra-Aortic And Control). FDA records list 58 510(k) clearances for Kontron Instruments, Inc., from to . As of , FDA records show no recalls naming K820166.

Clearance record

Decision date
Received
(98 days to decision)
Product code
DSP System, Balloon, Intra-Aortic And Control
Regulation
21 CFR 870.3535
Device class
Class II
Review panel
Cardiovascular
Applicant
Kontron Instruments, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DSP

Trailing 12 months

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

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