510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083451Substantially Equivalent

Portex Epidural Filter, Model 100/386/010, Various Standard and Custom Trays

Abbott Medical, Keene NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083451 is the FDA 510(k) clearance record for PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS, a class II device, cleared for Smiths Medical Asd, Inc. on under FDA product code BSN (Filter, Conduction, Anesthetic). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K083451.

Clearance record

Decision date
Received
(103 days to decision)
Product code
BSN Filter, Conduction, Anesthetic
Regulation
21 CFR 868.5130
Device class
Class II
Review panel
Anesthesiology
Applicant
Smiths Medical Asd, Inc. 10 Bowman Dr., Keene NH
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