510(k) · Cleared
ClearedIlwait Timer Oculopressor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oryx Medical Pty, Ltd. · LCC Applicator, Ocular Pressure
Cleared on May 10, 2012 as substantially equivalent to K820526 (The Lebanon Corp., 1982) after a 218-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- May 10, 2012
- Review
- 218 days
- Class
- Class II
- Product code
- LCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K820526 (1982). No later device cites it as a predicate yet.
- Root · 1 generation backK820526 Relief Valve-Honan Intraoc. PressureThe Lebanon Corp. · 1982
- This deviceK112952 Ilwait Timer OculopressorOryx Medical Pty, Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820526 | Relief Valve-Honan Intraoc. Pressure | The Lebanon Corp. | 1982 | — |
| 0 (this device) | K112952 | Ilwait Timer Oculopressor | Oryx Medical Pty, Ltd. | 2012 | — |
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 LCC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K820526 | Relief Valve-Honan Intraoc. PressureSummary page 2…ristics with Predicate Devices: Oryx Medical makes a Substantial Equivalence claim for the ilwait timer oculopressor to the Honan Intraocular Pressure Reducer, 5 10(k) # K820526. Both devices are used for the same application of reducing ocular pressure prior to ophthalmic surgery. Both devices are similar… | 1982 |
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.
How does its category compare?
All LCC devicesLCC Applicator, Ocular Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LCC
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LCC
Too few LCC 510(k)s in any year since 2007 to give a median.
Recalls per year · LCC
No recall names LCC since 2007.
Adverse event reports per year · LCC
No MAUDE report names LCC since 2007.
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 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ilwait timer oculopressor device is used to perform pre-operative ocular compression.
The device is used in the clinical and pit-operative ward, when the patient is supine, sedated and accompanied by a medical staff member.
The mass of the ilwait timer oculopressor provides even pressure across the eyelid to soften the eye.
The timer function provides a reminder to monitor the compression duration
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112952 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112952: Ilwait Timer Oculopressor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112952
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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