510(k) · Cleared
ClearedColonoscopy Assistant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sti Medical Systems, LLC · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Jun 15, 2011 as substantially equivalent to K043324 (KARL STORZ Endoscopy-America, Inc., 2005) after a 253-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Jun 15, 2011
- Review
- 253 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924178 (1993). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK924178 Medvision (TM) Imaging SoftwareEvergreen Technologies, Inc. · 1993
- 3 generations backK970064 Amicas Web/Intranet Image ServerAutocyt Group, Inc. · 1997
- 2 generations backK973131 Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Siemens Medical Solutions USA, Inc. · 1997
- 1 generation backK043324 Aida with Dicom and HL7 InterfaceKARL STORZ Endoscopy-America, Inc. · 2005
- This deviceK102949 Colonoscopy AssistantSti Medical Systems, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924178 | Medvision (TM) Imaging Software | Evergreen Technologies, Inc. | 1993 | — |
| −3 | K970064 | Amicas Web/Intranet Image Server | Autocyt Group, Inc. | 1997 | — |
| −2 | K973131 | Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway) | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −1 | K043324 | Aida with Dicom and HL7 Interface | KARL STORZ Endoscopy-America, Inc. | 2005 | — |
| 0 (this device) | K102949 | Colonoscopy Assistant | Sti Medical Systems, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1997 | 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 FET? 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 FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 generations · 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 |
|---|---|---|---|
| * | K043324 | Aida with Dicom and HL7 InterfaceSummary page 1…Class II Product Code: FET Advisory Panel: Gastroenterology-Urology 3. Predicate Device: Karl Storz AIDA with DICOM and HL7 Interface (K043324) 4. Device Description: Colonoscopy Assistant is a software application designed to provide a streamlined clinica… | 2005 |
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 18 years and passes through 5 companies; a new generation was cleared every 6.2 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K043324.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
What is it indicated for?
This software is an accessory to standard colonoscopy. It is intended for use in the viewing, recording, archival, localization, documentation, and retrieval of still images, video, and patient data during and after a standard colonoscopic procedure. Standard colonoscopy is indicated for the evaluation of results from an abnormality on barium enema or other imaging study, unexplained gastrointestinal bleeding, screening and surveillance for colonic neoplasia, the excision of a colonic polyp, or the management of chronic inflammatory bowel disease.
Captured, compressed videos from previous exams are for viewing and reference purposes and are not intended for primary diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102949 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102949: Colonoscopy Assistant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102949
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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