# K180627: Macroduct Advanced Model 3710

- Pathway: 510(k) (Traditional)
- Applicant: Elitechgroup, Inc.
- Decided: Jul 27, 2018 after 140 days
- Product code: KTB (Device, Iontophoresis, Specific Uses)
- Device class: 2
- Regulation: 21 CFR 890.5525
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K853973 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853973: Wescor Model 3700 Webster Sweat Inducer, Wescor, Inc. (1985) Summary page 4.

## Indications for use
The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.

Source page: https://510kreport.com/device/K180627
Methodology: https://510kreport.com/methodology