510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984528Substantially Equivalent

Parker Flex-Tip Tracheal Tube

Parker Medical Assoc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984528 is the FDA 510(k) clearance record for PARKER FLEX-TIP TRACHEAL TUBE, a class II device, cleared for Parker Medical Assoc. on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list one 510(k) clearance for Parker Medical Assoc. As of , FDA records show one recall naming K984528.

Clearance record

Decision date
Received
(206 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Parker Medical Assoc. 109 Inverness Dr. E.,, Englewood CO
510(k) summary
Summary
Third party review
No

Clearances, product code BTR

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