510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K791648Substantially Equivalent

Model 54 Flowmeter Back-Pressure Tube

Harris Calorific, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K791648 is the FDA 510(k) clearance record for MODEL 54 FLOWMETER BACK-PRESSURE TUBE, a class I device, cleared for Harris Calorific on under FDA product code CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated). FDA records list 2 510(k) clearances for Harris Calorific, from to . As of , FDA records show no recalls naming K791648.

Clearance record

Decision date
Received
(24 days to decision)
Product code
CAX Flowmeter, Tube, Thorpe, Back-Pressure Compensated
Regulation
21 CFR 868.2340
Device class
Class I
Review panel
Anesthesiology
Applicant
Harris Calorific 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CAX

Trailing 12 months

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

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