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
K830898Substantially Equivalent

Syringe 500Bc Be #7000

Instrumentation Industries, Incorporated, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830898 is the FDA 510(k) clearance record for SYRINGE 500BC BE #7000, a class I device, cleared for Instrumentation Industries, Inc. on under FDA product code BXW (Calibrator, Volume, Gas). FDA records list 45 510(k) clearances for INSTRUMENTATION INDUSTRIES, INCORPORATED, from to . As of , FDA records show no recalls naming K830898.

Clearance record

Decision date
Received
(56 days to decision)
Product code
BXW Calibrator, Volume, Gas
Regulation
21 CFR 868.1870
Device class
Class I
Review panel
Anesthesiology
Applicant
Instrumentation Industries, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BXW

Trailing 12 months

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

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