# 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)

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Oct 7, 2021 after 29 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: 6 generations back to K853585 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190512: SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare, Intelligent Endoscopy (2019) Summary page 5.

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

Source page: https://510kreport.com/device/K212860
Methodology: https://510kreport.com/methodology