510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K000045Substantially Equivalent

Positube

Paraproducts, Inc., Itasca IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000045 is the FDA 510(k) clearance record for POSITUBE, a class II device, cleared for Paraproducts, Inc. on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list one 510(k) clearance for Paraproducts, Inc. As of , FDA records show no recalls naming K000045.

Clearance record

Decision date
Received
(68 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Paraproducts, Inc. 1431 Industrial Dr., Itasca IL
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