510(k) · Cleared
ClearedEndoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · OCU Endoscopic Storage Cover
Cleared on Jan 27, 2020 as substantially equivalent to K951104 (United States Endoscopy Group, Inc., 1995) after a 215-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jan 27, 2020
- Review
- 215 days
- Class
- Class II
- Product code
- OCU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951104 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951104 EndobootUnited States Endoscopy Group, Inc. · 1995
- This deviceK191715 Endoscope Tip Protector - Sterile, Endoscope Tip Protector -…STERIS Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951104 | Endoboot | United States Endoscopy Group, Inc. | 1995 | — |
| 0 (this device) | K191715 | Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile | STERIS Corporation | 2020 | — |
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 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
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 |
|---|---|---|---|
| * | K951104 | EndobootSummary page 5…Classification Name: Endoscope and accessories Classification Number: 21 CFR 876.1500 Product Code: OCU 2. Predicate Device K951104 Endo-boot – endoscope tip protector 3. Description of Device The Endoscope Tip Protector is a single-use molde… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K951104.
How does its category compare?
All OCU devicesOCU Endoscopic Storage Cover: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Endoscope Tip Protector is intended to be used on the distal tip of an endoscope for the purpose of protecting the endoscope's delicate lens and the endoscope's bending rubber during transport and storage. It may also be used on the distal tip of medical/surgical instruments to protect delicate components/mechanisms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191715: Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191715
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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