510(k) · Cleared
Recalled · 2003Microvasive Maxforce
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 May 16, 1994 after a 228-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- May 16, 1994
- Review
- 228 days
- Class
- Class II
- Product code
- KNQ
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK934697 Microvasive MaxforceBoston Scientific Corp · 1994
- Descendant · cites it directly · 3 of its ownK061787 Maxforce TTS Single-Use Balloon DilatorBoston Scientific Corp · 2006
- Descendant · 2 generations on · 2 of its ownK111030 E.G. Scan (TM) Esophagoscope SystemIntromedic Co., Ltd. · 2011
- Descendant · 3 generations on · 1 of its ownK120702 E.G. Scan II Esphagoscope SystemIntromedic Co., Ltd. · 2012
- Descendant · 4 generations on · 0 of its ownK131131 E.G. Scan (TM) II Esophagoscope SystemIntromedic Co., Ltd. · 2013
Most influential descendants
Showing 4 of 4 · See all- K061787Maxforce TTS Single-Use Balloon DilatorBoston Scientific Corp · 2006 · cites it directly3descendants
- K111030E.G. Scan (TM) Esophagoscope SystemIntromedic Co., Ltd. · 2011 · 2 generations on2descendants
- K120702E.G. Scan II Esphagoscope SystemIntromedic Co., Ltd. · 2012 · 3 generations on1descendant
- K131131E.G. Scan (TM) II Esophagoscope SystemIntromedic Co., Ltd. · 2013 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934697 | Microvasive Maxforce | Boston Scientific Corp | 1994 | — |
| +1 | K061787 | Maxforce TTS Single-Use Balloon Dilator | Boston Scientific Corp | 2006 | — |
| +2 | K111030 | E.G. Scan (TM) Esophagoscope System | Intromedic Co., Ltd. | 2011 | — |
| +3 | K120702 | E.G. Scan II Esphagoscope System | Intromedic Co., Ltd. | 2012 | — |
| +4 | K131131 | E.G. Scan (TM) II Esophagoscope System | Intromedic Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061787 | Maxforce TTS Single-Use Balloon Dilator | 2006 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 29, 2003 | Not classified | Z-0831-03 | Other | Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061787 (Boston Scientific Corp, 2006) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K934697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934697: Microvasive Maxforce.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934697
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026