# K190512: SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Endoscopy
- Decided: Nov 22, 2019 after 266 days
- Product code: FDI (Snare, Flexible)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K853585 (1986). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140726: Captivator Emr Device for Standard Gastroscopes - Box 1, Captivator Emr Device for Standard Gastroscopes - Box 5, Captiv, Boston Scientific Corp (2014) Summary page 4.

## Most influential descendants
- K212860: SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) (2021), 0 descendants of its own

## Indications for use
The SmartBand® EMR Device is intended for endoscopic mucosal resection in the upper GI tract.

Source page: https://510kreport.com/device/K190512
Methodology: https://510kreport.com/methodology