510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853478Substantially Equivalent

Pinpoint Needle

Regional Master Corp., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853478 is the FDA 510(k) clearance record for PINPOINT NEEDLE, a class II device, cleared for Regional Master Corp. on under FDA product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). FDA records list 4 510(k) clearances for Regional Master Corp., from to . As of , FDA records show no recalls naming K853478.

Clearance record

Decision date
Received
(154 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
Regional Master Corp. P.O. Box 431832, Miami 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