510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853848Substantially Equivalent

Respiratory Diagnostic Equipment Calibrator

Medical Graphics Corp., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853848 is the FDA 510(k) clearance record for RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR, a class I device, cleared for Medical Graphics Corp. on under FDA product code BXW (Calibrator, Volume, Gas). FDA records list 25 510(k) clearances for Medical Graphics Corp., from to . As of , FDA records show no recalls naming K853848.

Clearance record

Decision date
Received
(80 days to decision)
Product code
BXW Calibrator, Volume, Gas
Regulation
21 CFR 868.1870
Device class
Class I
Review panel
Anesthesiology
Applicant
Medical Graphics Corp. 501 W. County Rd. E, St. Paul MN
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