510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K881514Substantially Equivalent

Pristine Specimen Tube and Introducer System

Hall Laboratories, Inc., Shawnee KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881514 is the FDA 510(k) clearance record for PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM, a class II device, cleared for Hall Laboratories, Inc. on under FDA product code BSK (Cuff, Tracheal Tube, Inflatable). FDA records list 2 510(k) clearances for Hall Laboratories, Inc., from to . As of , FDA records show no recalls naming K881514.

Clearance record

Decision date
Received
(66 days to decision)
Product code
BSK Cuff, Tracheal Tube, Inflatable
Regulation
21 CFR 868.5750
Device class
Class II
Review panel
Anesthesiology
Applicant
Hall Laboratories, Inc. 5751 Richards Cir., Shawnee KS
Third party review
No

Clearances, product code BSK

Trailing 12 months
1 clearance under product code BSK in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BSK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260