510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831800Substantially Equivalent

Texas Interface Pressure Evaluator-Tipe

Tee-Kay Applied Technology, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831800 is the FDA 510(k) clearance record for TEXAS INTERFACE PRESSURE EVALUATOR-TIPE, a class I device, cleared for Tee-Kay Applied Technology on under FDA product code JFC (System, Pressure Measurement, Intermittent). FDA records list one 510(k) clearance for Tee-Kay Applied Technology. As of , FDA records show no recalls naming K831800.

Clearance record

Decision date
Received
(85 days to decision)
Product code
JFC System, Pressure Measurement, Intermittent
Regulation
21 CFR 890.1600
Device class
Class I
Review panel
Physical Medicine
Applicant
Tee-Kay Applied Technology 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JFC

Trailing 12 months

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

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