510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K960928Substantially Equivalent

Syringefilter

Arbor Technologies, Inc., Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960928 is the FDA 510(k) clearance record for SYRINGEFILTER, a class II device, cleared for Arbor Technologies, Inc. on under FDA product code BSN (Filter, Conduction, Anesthetic). FDA records list 10 510(k) clearances for Arbor Technologies, Inc., from to . As of , FDA records show no recalls naming K960928.

Clearance record

Decision date
Received
(393 days to decision)
Product code
BSN Filter, Conduction, Anesthetic
Regulation
21 CFR 868.5130
Device class
Class II
Review panel
Anesthesiology
Applicant
Arbor Technologies, Inc. 401 W. Morgan Rd., Ann Arbor MI
510(k) summary
Summary
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