510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190663Substantially Equivalent

Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6

Pajunk GmbH Medizintechnologie, Geisingen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190663 is the FDA 510(k) clearance record for Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6, a class II device, cleared for PAJUNK GmbH Medizintechnologie on under FDA product code BSN (Filter, Conduction, Anesthetic). FDA records list 63 510(k) clearances for PAJUNK GmbH Medizintechnologie, from to . As of , FDA records show no recalls naming K190663.

Clearance record

Decision date
Received
(94 days to decision)
Product code
BSN Filter, Conduction, Anesthetic
Regulation
21 CFR 868.5130
Device class
Class II
Review panel
Anesthesiology
Applicant
PAJUNK GmbH Medizintechnologie Karl-Hall-Str 1, Geisingen, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BSN

Trailing 12 months

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

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