510(k) · Cleared
ClearedProtectiscope CS Colonoscope, Non-Intrapull
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GI · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on May 2, 2008 as substantially equivalent to K032688 (Sightline Technologies, Ltd., 2004) after a 24-day review. Its family tree reaches back 5 generations to 1992. 9 later devices descend from it.
- Decided
- May 2, 2008
- Review
- 24 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K921244 (1992). 21 ancestors in all, the oldest K822846 (1982). 9 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 4 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 3 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 2 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 1 generation backK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
- This deviceK081004 Protectiscope CS Colonoscope, Non-IntrapullStryker GI · 2008
- Descendant · cites it directly · 6 of its ownK120289 Peerscope SystemPeermedical · 2012
- Descendant · 2 generations on · 5 of its ownK130718 Peerscope SystemPeermedical, Ltd. · 2013
- Descendant · 3 generations on · 2 of its ownK132839 Fuse 1C Colonoscopy SystemEndochoice, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK131422 Peerscope SystemEndochoice, Inc. · 2013
- Descendant · 4 generations on · 1 of its ownK152182 Fuse Gastroscopy SystemEndochoice, Inc. · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K120289Peerscope SystemPeermedical · 2012 · cites it directly6descendants
- K130718Peerscope SystemPeermedical, Ltd. · 2013 · 2 generations on5descendants
- K132839Fuse 1C Colonoscopy SystemEndochoice, Inc. · 2014 · 3 generations on2descendants
- K131422Peerscope SystemEndochoice, Inc. · 2013 · 3 generations on2descendants
- K152182Fuse Gastroscopy SystemEndochoice, Inc. · 2015 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −4 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −3 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −2 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −1 | K032688 | Colonosight Model 510B | Sightline Technologies, Ltd. | 2004 | — |
| 0 (this device) | K081004 | Protectiscope CS Colonoscope, Non-Intrapull | Stryker GI | 2008 | — |
| +1 | K120289 | Peerscope System | Peermedical | 2012 | — |
| +2 | K130718 | Peerscope System | Peermedical, Ltd. | 2013 | — |
| +3 | K132839 | Fuse 1C Colonoscopy System | Endochoice, Inc. | 2014 | — |
| +3 | K131422 | Peerscope System | Endochoice, Inc. | 2013 | — |
| +4 | K152182 | Fuse Gastroscopy System | Endochoice, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K032688 | Colonosight Model 510BSummary page 2…ns. Substantial Equivalence: The Protectiscope CS, non-intrapull device included in this submission is a modification to the to the ColonoSight 520B device cleared in K032688. The sole modification is the removal of the air assisted push technology feature of the device. The current design of the Protec… | 2004 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3.7 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K120289 (Peermedical, 2012) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K032688.
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. 2008, this device’s year, is highlighted.
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?
Intended to provide visualization (via a video monitor) and therapeutic access to the lower gastrointestinal tract including, but not limited to the organs, tissues, and subsystems of the large bowel. The device is introduced rectally as with any standard colonoscope, when indications consistent with the requirement for the procedure are observed in adult patient populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081004 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081004: Protectiscope CS Colonoscope, Non-Intrapull.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081004
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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