510(k) · Cleared
ClearedMaxforce TTS Single-Use Balloon Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · KNQ Dilator, Esophageal
Cleared on Sep 21, 2006 as substantially equivalent to K934697 (Boston Scientific Corp, 1994) after an 87-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Sep 21, 2006
- Review
- 87 days
- Class
- Class II
- Product code
- KNQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934697 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK934697 Microvasive MaxforceBoston Scientific Corp · 1994 · Recalled
- This deviceK061787 Maxforce TTS Single-Use Balloon DilatorBoston Scientific Corp · 2006
- Descendant · cites it directly · 2 of its ownK111030 E.G. Scan (TM) Esophagoscope SystemIntromedic Co., Ltd. · 2011
- Descendant · 2 generations on · 1 of its ownK120702 E.G. Scan II Esphagoscope SystemIntromedic Co., Ltd. · 2012
- Descendant · 3 generations on · 0 of its ownK131131 E.G. Scan (TM) II Esophagoscope SystemIntromedic Co., Ltd. · 2013
Most influential descendants
Showing 3 of 3 · See all- K111030E.G. Scan (TM) Esophagoscope SystemIntromedic Co., Ltd. · 2011 · cites it directly2descendants
- K120702E.G. Scan II Esphagoscope SystemIntromedic Co., Ltd. · 2012 · 2 generations on1descendant
- K131131E.G. Scan (TM) II Esophagoscope SystemIntromedic Co., Ltd. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934697 | Microvasive Maxforce | Boston Scientific Corp | 1994 | 1 |
| 0 (this device) | K061787 | Maxforce TTS Single-Use Balloon Dilator | Boston Scientific Corp | 2006 | — |
| +1 | K111030 | E.G. Scan (TM) Esophagoscope System | Intromedic Co., Ltd. | 2011 | — |
| +2 | K120702 | E.G. Scan II Esphagoscope System | Intromedic Co., Ltd. | 2012 | — |
| +3 | K131131 | E.G. Scan (TM) II Esophagoscope System | Intromedic Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 KNQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K934697 | Microvasive MaxforceSummary page 1…Class 11, per 21 CFR Part 876, Section 5365 PREDICATE DEVICE: Boston Scientific Maxlbrc' IT'S Single-Use Balloon Dilator (K934697). DEVICE DESCRIPTION: The Maxforce TTS Single-Use Balloon Dilator consists of a distal tip, balloon, cathete… | 1994 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111030 | E.G. Scan (TM) Esophagoscope System | 2011 | 2 |
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?
- Its one ancestor has a recall.
- Of its descendants, K111030 (Intromedic Co., Ltd., 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KNQ devicesKNQ Dilator, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNQ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KNQ
121in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNQ
14in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNQ
282in 2025
MAUDE reports naming product code KNQ, 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 | — | 14 | 22 |
| 2008 | 0 | — | 0 | 128 |
| 2009 | 3 | 121 | 0 | 391 |
| 2010 | 0 | — | 0 | 176 |
| 2011 | 0 | — | 0 | 251 |
| 2012 | 1 | — | 0 | 251 |
| 2013 | 0 | — | 0 | 228 |
| 2014 | 0 | — | 0 | 164 |
| 2015 | 0 | — | 0 | 204 |
| 2016 | 0 | — | 0 | 154 |
| 2017 | 0 | — | 0 | 231 |
| 2018 | 0 | — | 0 | 396 |
| 2019 | 0 | — | 0 | 388 |
| 2020 | 0 | — | 0 | 364 |
| 2021 | 0 | — | 0 | 351 |
| 2022 | 0 | — | 0 | 274 |
| 2023 | 0 | — | 0 | 319 |
| 2024 | 0 | — | 0 | 268 |
| 2025 | 0 | — | 0 | 282 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
The proposed Maxforce TTS Single-Use Balloon Dilator is indicated for use in adults and adolescent populations to endoscopically dilate strictures of the esophagus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061787 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061787: Maxforce TTS Single-Use Balloon Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061787
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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