510(k) · Cleared
ClearedEndoboot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Endoscopy Group, Inc. · OCU Endoscopic Storage Cover
Cleared on Apr 6, 1995 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Apr 6, 1995
- Review
- 27 days
- Class
- Class II
- Product code
- OCU
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK951104 EndobootUnited States Endoscopy Group, Inc. · 1995
- Descendant · cites it directly · 1 of its ownK191011 Scope ProTechMeditech Endoscopy, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK202838 Andorate Universal Endoscope Tip GuardGa Health Company Limited · 2021
- Descendant · cites it directly · 0 of its ownK191715 Endoscope Tip Protector - Sterile, Endoscope Tip Protector -…STERIS Corporation · 2020
Most influential descendants
Showing 3 of 3 · See all- K191011Scope ProTechMeditech Endoscopy, Ltd. · 2019 · cites it directly1descendant
- K202838Andorate Universal Endoscope Tip GuardGa Health Company Limited · 2021 · 2 generations on0descendants
- K191715Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterileSTERIS Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951104 | Endoboot | United States Endoscopy Group, Inc. | 1995 | — |
| +1 | K191011 | Scope ProTech | Meditech Endoscopy, Ltd. | 2019 | — |
| +2 | K202838 | Andorate Universal Endoscope Tip Guard | Ga Health Company Limited | 2021 | — |
| +1 | K191715 | Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile | STERIS Corporation | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 OCU? 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 OCU device
- #1 K202838 Andorate Universal Endoscope Tip Guardscore 1.3 · 2 generations · no Class I recall
- #2 Held for the reportin 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? (3)
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?
- Of its descendants, K191011 (Meditech Endoscopy, Ltd., 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OCU devicesOCU Endoscopic Storage Cover: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCU
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OCU
Too few OCU 510(k)s in any year since 2007 to give a median.
Recalls per year · OCU
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCU
1in 2016
MAUDE reports naming product code OCU, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K951104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951104: Endoboot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951104
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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