WELL LEAD ENDOBRONCHIAL TUBES— 510(k) K092886

Clearance details

Applicant

Well Lead Instruments

Product code

Code CBI

Device class

Class 2

Regulation

21 CFR 868.5740

Advisory panel

Anesthesiology

Date received

2009-09-21

Decision date

2010-03-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Apollo Beach, FL, US

• K251950 — Endobronchial Blocker Tube (12 models)2026-03-20
• K253096 — Chartis Precision Catheter2026-02-13
• K232529 — Disposable Double Lumen Endobronchial Tube2024-05-13
• K232580 — Disposable Endobronchial Blocker Tube2023-12-14
• K222340 — Chartis Precision Catheter2022-12-01

Death

4

Malfunction

594

Total

598

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1399-2017 — Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients and used in conjunction with a ventilator to provide oxygen and anesthetic agents to the patient during surgeriesClass II·Terminated·Parker Medical·20161216

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092886.