510(k) · Cleared
Recalled · Class II · 2024InstaClear Lens Cleaner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Jan 15, 2016 as substantially equivalent to K982594 (Xomed, Inc., 1998) after a 134-day review. Its family tree reaches back 2 generations to 1990. It has been recalled 2 times.
- Decided
- Jan 15, 2016
- Review
- 134 days
- Class
- Class II
- Product code
- EOB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902683 (1990). 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 EOB? 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 EOB device
- #1 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 12 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 |
|---|---|---|---|
| * | K982594 | Endo-Scrub/Endo-Scrub 2Summary page 5…cation Gyrus ACMI, Inc. Sept 2015 Predicate Device Medtronic Endo-scrub 2: K982594 Product Description The InstaClear Lens Cleaner system is equivalent to the predicate device cleared under K982594. The system… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 3, 2024 | Class II | Z-1888-2024 | Under Investigation by firm | Potential for distal end of the sheath to break off during a procedure. |
| Jan 16, 2024 | Class II | Z-1368-2024 | Under Investigation by firm | Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be updated to reflect… |
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 17.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K982594.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · EOB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOB
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EOB
1,338in 2025
MAUDE reports naming product code EOB, 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 | 37 | 0 | 1 |
| 2008 | 4 | 38 | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 209 | 2 | 3 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 3 | 282 | 0 | 5 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 3 | 174 | 0 | 16 |
| 2017 | 6 | 216 | 0 | 18 |
| 2018 | 6 | 230 | 0 | 23 |
| 2019 | 8 | 149 | 0 | 51 |
| 2020 | 3 | 175 | 0 | 47 |
| 2021 | 2 | — | 0 | 345 |
| 2022 | 6 | 178 | 1 | 1,158 |
| 2023 | 3 | 107 | 1 | 1,352 |
| 2024 | 2 | — | 0 | 1,498 |
| 2025 | 3 | 192 | 0 | 1,338 |
| 2026 | 5 | 180 | 1 | — |
What is it indicated for?
Intended to clear the end of a rigid rod endoscope in order to maintain clear visualization of endoscopic procedures without having to remove the scope from the surgical site.
The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152531: InstaClear Lens Cleaner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152531
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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