510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K920305Substantially Equivalent

Pharmaseal Clear Hub Spinal Needle

Baxter Healthcare Corporation, Valencia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920305 is the FDA 510(k) clearance record for PHARMASEAL CLEAR HUB SPINAL NEEDLE, a class II device, cleared for Baxter Healthcare Corp on under FDA product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K920305.

Clearance record

Decision date
Received
(371 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
Baxter Healthcare Corp 27200 N. Tourney Rd., Valencia CA
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BSP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260