510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963717Substantially Equivalent

Millex - Mp Filter Unit (Slmpo25ss/slmpl25ss)

EMD Millipore Corporation, Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963717 is the FDA 510(k) clearance record for MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS), a class II device, cleared for Millipore Corp. on under FDA product code BSN (Filter, Conduction, Anesthetic). FDA records list 94 510(k) clearances for EMD MILLIPORE CORPORATION, from to . As of , FDA records show no recalls naming K963717.

Clearance record

Decision date
Received
(267 days to decision)
Product code
BSN Filter, Conduction, Anesthetic
Regulation
21 CFR 868.5130
Device class
Class II
Review panel
Anesthesiology
Applicant
Millipore Corp. 80 Ashby Rd., Bedford MA
510(k) summary
Statement
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