# K102127: Endotracheal Tube Changers

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Industries, Inc.
- Decided: Aug 27, 2010 after 29 days
- Product code: LNZ (Changer, Tube, Endotracheal)
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. This device is intended for sale by or on the order of a physician.

Source page: https://510kreport.com/device/K102127
Methodology: https://510kreport.com/methodology