510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K896181Substantially Equivalent

Apt Trachea Tubes

Advanced Pulmonary Technologies, Inc., Glastonbury CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896181 is the FDA 510(k) clearance record for APT TRACHEA TUBES, a class II device, cleared for Advanced Pulmonary Technologies, Inc. on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list one 510(k) clearance for Advanced Pulmonary Technologies, Inc. As of , FDA records show no recalls naming K896181.

Clearance record

Decision date
Received
(76 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Advanced Pulmonary Technologies, Inc. 50 Nye Rd., Glastonbury CT
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