510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854816Substantially Equivalent

Epidural Anesthesia Needles

Reganes, Inc., Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854816 is the FDA 510(k) clearance record for EPIDURAL ANESTHESIA NEEDLES, a class II device, cleared for Reganes, Inc. on under FDA product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). FDA records list 2 510(k) clearances for Reganes, Inc., from to . As of , FDA records show 2 recalls naming K854816.

Clearance record

Decision date
Received
(16 days to decision)
Product code
BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Regulation
21 CFR 868.5150
Device class
Class II
Review panel
Anesthesiology
Applicant
Reganes, Inc. P.O. Box 13212, Clearwater FL
Third party review
No

Clearances, product code BSP

Trailing 12 months

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

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