510(k) · Cleared
ClearedInhealth Soft Sleeve Colonoscope Splint, Model CS1200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Helix Medical, Inc. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Dec 26, 2002 as substantially equivalent to K954451 (Olympus America, Inc., 1996) after an 87-day review. Its family tree reaches back 2 generations to 1986. 6 later devices descend from it.
- Decided
- Dec 26, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K853585 (1986). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 1 generation backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- This deviceK023259 Inhealth Soft Sleeve Colonoscope Splint, Model CS1200Helix Medical, Inc. · 2002
- Descendant · cites it directly · 5 of its ownK092221 Colonic Splinting Overtube, Model 00711145United States Endoscopy Group, Inc. · 2009
- Descendant · 2 generations on · 3 of its ownK100081 Enteroscopy Overtube, Model 00712140United States Endoscopy Group, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK110531 Endoflip EcdCrospon, Ltd. · 2011
- Descendant · 3 generations on · 0 of its ownK192691 PatCom Single-Use IntroducerH&A Mui Enterprises, Inc. · 2020
- Descendant · 4 generations on · 0 of its ownK150083 Sidecar External Working ChannelC2 Therapeutics · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K092221Colonic Splinting Overtube, Model 00711145United States Endoscopy Group, Inc. · 2009 · cites it directly5descendants
- K100081Enteroscopy Overtube, Model 00712140United States Endoscopy Group, Inc. · 2010 · 2 generations on3descendants
- K110531Endoflip EcdCrospon, Ltd. · 2011 · 3 generations on1descendant
- K192691PatCom Single-Use IntroducerH&A Mui Enterprises, Inc. · 2020 · 3 generations on0descendants
- K150083Sidecar External Working ChannelC2 Therapeutics · 2015 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −1 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| 0 (this device) | K023259 | Inhealth Soft Sleeve Colonoscope Splint, Model CS1200 | Helix Medical, Inc. | 2002 | — |
| +1 | K092221 | Colonic Splinting Overtube, Model 00711145 | United States Endoscopy Group, Inc. | 2009 | — |
| +2 | K100081 | Enteroscopy Overtube, Model 00712140 | United States Endoscopy Group, Inc. | 2010 | — |
| +3 | K110531 | Endoflip Ecd | Crospon, Ltd. | 2011 | — |
| +3 | K192691 | PatCom Single-Use Introducer | H&A Mui Enterprises, Inc. | 2020 | — |
| +4 | K150083 | Sidecar External Working Channel | C2 Therapeutics | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K954451 | Evis 140 SystemSummary page 1…es.” The product code for this device is FDF, Colonoscope, Gastro-Urology. 111. PREDICATE DEVICES 0 Olympus Splinting Tube, Olympus America, Inc., Melville, NY; K954451 0 Pentax Splinting Tube, Pentax Precision Inst., Orangeburg, NY; K# Unknown ACMl Splinting Tube, AMCl Corporation,… | 1996 |
| * | — | Pentax Splinting Tube Named without a submission number | |
| * | — | ACMI Splinting Tube Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092221 | Colonic Splinting Overtube, Model 00711145 | 2009 | 5 |
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 16 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K092221 (United States Endoscopy Group, Inc., 2009) has gone furthest, with 5 descendants of its own.
- 9 other devices also cite its predicate K954451.
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 InHealth Soft Sleeve Colonoscope Splint is indicated for use with a colonoscope to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the colonoscope during the colonoscopy procedure. The InHealth Soft Sleeve Colonoscope Splint is intended to provide for easy advancement of the scope while avoiding damage to the colon.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023259: Inhealth Soft Sleeve Colonoscope Splint, Model CS1200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023259
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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