510(k) · Cleared
ClearedSmartBand 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)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FDI Snare, Flexible
Cleared on Oct 7, 2021 as substantially equivalent to K190512 (Intelligent Endoscopy, 2019) after a 29-day review. Its family tree reaches back 6 generations to 1986.
- Decided
- Oct 7, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- FDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K853585 (1986). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 5 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 4 generations backK984358 Olympus Distal Attachment, Models…Olympus America, Inc. · 1999 · Recalled
- 3 generations backK050578 Cook Ireland Duette Multi-Band Mucosectomy DeviceCook Ireland, Ltd. · 2005
- 2 generations backK140726 Captivator Emr Device for Standard Gastroscopes - Box 1, Captivator…Boston Scientific Corp · 2014
- 1 generation backK190512 SmartBand EMR Kit, SmartBand EMR Pack, SmartSnareIntelligent Endoscopy · 2019
- This deviceK212860 SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand…STERIS Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −5 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −4 | K984358 | Olympus Distal Attachment, Models… | Olympus America, Inc. | 1999 | 2 |
| −3 | K050578 | Cook Ireland Duette Multi-Band Mucosectomy Device | Cook Ireland, Ltd. | 2005 | — |
| −2 | K140726 | Captivator Emr Device for Standard Gastroscopes - Box 1, Captivator Emr Device… | Boston Scientific Corp | 2014 | — |
| −1 | K190512 | SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare | Intelligent Endoscopy | 2019 | — |
| 0 (this device) | K212860 | SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack… | STERIS Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FDI device
- #1 K251692 Advanced Tissue Resection Devicescore 10.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190512 | SmartBand EMR Kit, SmartBand EMR Pack, SmartSnareSummary page 5…MR Kit (SB-EMR-K, SB-EMR-K-12) SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12) SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with Kit) All cleared under K190512 3. Device Description The SmartBand EMR Device is an endoscopic mucosal resection device that is provided as a kit o… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 6 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 7 ancestors have a recall of any class.
How does its category compare?
All FDI devicesFDI Snare, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FDI
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FDI
247in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDI
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDI
274in 2025
MAUDE reports naming product code FDI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 48 |
| 2008 | 2 | — | 0 | 201 |
| 2009 | 1 | — | 0 | 265 |
| 2010 | 0 | — | 1 | 174 |
| 2011 | 1 | — | 0 | 177 |
| 2012 | 1 | — | 0 | 162 |
| 2013 | 3 | 87 | 0 | 191 |
| 2014 | 5 | 47 | 0 | 345 |
| 2015 | 3 | 62 | 1 | 195 |
| 2016 | 1 | — | 0 | 223 |
| 2017 | 1 | — | 0 | 154 |
| 2018 | 4 | 214 | 0 | 181 |
| 2019 | 3 | 100 | 0 | 135 |
| 2020 | 2 | — | 0 | 487 |
| 2021 | 1 | — | 0 | 211 |
| 2022 | 4 | 247 | 0 | 246 |
| 2023 | 1 | — | 0 | 209 |
| 2024 | 0 | — | 0 | 279 |
| 2025 | 0 | — | 2 | 274 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SmartBand® EMR Device is intended for endoscopic mucosal resection in the upper GI tract.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212860 · printed Nov 4, 2026
Cite this page
510(k) Report. “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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212860
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026