510(k) · Cleared
ClearedAndorate Universal Endoscope Tip Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ga Health Company Limited · OCU Endoscopic Storage Cover
Cleared on Mar 5, 2021 as substantially equivalent to K191011 (Meditech Endoscopy, Ltd., 2019) after a 161-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Mar 5, 2021
- Review
- 161 days
- Class
- Class II
- Product code
- OCU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K951104 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K191715 Endoscope Tip Protector - Sterile, Endoscope…score -1.3 · 1 generation · 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 |
|---|---|---|---|
| * | K191011 | Scope ProTechSummary page 5…: 2 Device Panel Gastroenterology/Urology 5. Predicate Device Identification Predicate Device 510(k) No.: K191011 Predicate Device Trade Name: Scope ProTech Predicate Device Product Code: OCU – Endoscopic Storage Cover… | 2019 |
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?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 24.1 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All OCU devicesOCU Endoscopic Storage Cover: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Universal Endoscope Tip Guard is intended to protect tip of the endoscope during transport and storage. It is not intended for use during sterilization.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202838: Andorate Universal Endoscope Tip Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202838
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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