510(k) · Cleared
ClearedZutron Colonoscope Stiffening Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zutron Medical · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Jul 11, 2005 as substantially equivalent to K901610 (Wilson-Cook Medical, Inc., 1990) and 3 other predicates after a 76-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Jul 11, 2005
- Review
- 76 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K931650 (1993). 10 ancestors in all, the oldest K901610 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK931650 Microvasive Insurg Geenen CBD Guide WireBoston Scientific Corp · 1993
- 2 generations backK964955 Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands…Flexmedics · 1997
- 1 generation backK023603 Endo-Glide GuidewireEndo-Therapeutics, Inc. · 2003
- This deviceK051068 Zutron Colonoscope Stiffening DeviceZutron Medical · 2005
- Descendant · cites it directly · 0 of its ownK251204 FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation · 2025
Most influential descendants
Showing 1 of 1 · See all- K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931650 | Microvasive Insurg Geenen CBD Guide Wire | Boston Scientific Corp | 1993 | — |
| −2 | K964955 | Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands… | Flexmedics | 1997 | — |
| −1 | K023603 | Endo-Glide Guidewire | Endo-Therapeutics, Inc. | 2003 | — |
| 0 (this device) | K051068 | Zutron Colonoscope Stiffening Device | Zutron Medical | 2005 | — |
| +1 | K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | FUJIFILM Healthcare Americas Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 FDF? 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 FDF device
- #1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K901610 | Sullivan Variable Stiffness CableSummary page 1…ly as 1972 reference the use of steel wires for the stiffening of colonoscopes) * Guide Wires and Cables o Sullivan Variable Stiffness Cable, K901610, Wilson Cook Medical, Product Code KOG o GIP / Medi-Globe Guide Wires, K941973, Medi-Globe Corp, Product Code FGE… | 1990 |
| * | K941973 | Gip/Medi-Globe Guide Wires & Wind-UP Guide WiresSummary page 1…* Guide Wires and Cables o Sullivan Variable Stiffness Cable, K901610, Wilson Cook Medical, Product Code KOG o GIP / Medi-Globe Guide Wires, K941973, Medi-Globe Corp, Product Code FGE o GIP / Medi-Globe, Stiffy Variable Stiffness Guide Wire, 510(k) Unknown, Medi-G… | 1995 |
| * | K023603 | Endo-Glide GuidewireSummary page 1…P / Medi-Globe, Stiffy Variable Stiffness Guide Wire, 510(k) Unknown, Medi-Globe Corp, Product Code not specified o Endo-Glide Guidewire, K023603, Endo-Therapeutics Inc., Product Code KOG * Colonoscopes with Stiffness Controls o Olympus PCF-160AL/I, K00124… | 2003 |
| * | K001241 | Evis Exera Colonovideoscope CF-Q160 AL/I and PCF-160 AL/ISummary page 1…o Endo-Glide Guidewire, K023603, Endo-Therapeutics Inc., Product Code KOG * Colonoscopes with Stiffness Controls o Olympus PCF-160AL/I, K001241, Olympus Optical, Product Code FDF (5) Intended Use: The intended use of the device is to allow the physician to increase th… | 2000 |
| * | — | Steel Wire Named without a submission number | |
| * | — | GIP / Medi-Globe, Stiffy Variable Stiffness Guide Wire Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | 2025 | 0 |
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 12 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K251204 (FUJIFILM Healthcare Americas Corporation, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FDF devicesFDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FDF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDF
194in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDF
8in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDF
17,231in 2025
MAUDE reports naming product code FDF, 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 | 4 | 70 | 0 | 81 |
| 2008 | 2 | — | 0 | 68 |
| 2009 | 6 | 91 | 0 | 83 |
| 2010 | 4 | 101 | 0 | 48 |
| 2011 | 2 | — | 0 | 77 |
| 2012 | 7 | 241 | 0 | 88 |
| 2013 | 2 | — | 0 | 63 |
| 2014 | 6 | 164 | 0 | 60 |
| 2015 | 2 | — | 1 | 100 |
| 2016 | 7 | 98 | 1 | 170 |
| 2017 | 4 | 36 | 0 | 370 |
| 2018 | 7 | 101 | 0 | 388 |
| 2019 | 4 | 56 | 0 | 417 |
| 2020 | 4 | 250 | 1 | 687 |
| 2021 | 3 | 30 | 0 | 2,444 |
| 2022 | 5 | 147 | 0 | 8,345 |
| 2023 | 6 | 203 | 8 | 11,748 |
| 2024 | 2 | — | 0 | 12,128 |
| 2025 | 4 | 194 | 0 | 17,231 |
| 2026 | 5 | 147 | 0 | — |
What is it indicated for?
The intended use of the device is to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051068 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051068: Zutron Colonoscope Stiffening Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051068
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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