510(k) · Cleared
ClearedBlink External Eyelid Weight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ipax, Inc. · MML Weights, Eyelid, External
Cleared on Jun 20, 1997 after a 78-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 20, 1997
- Review
- 78 days
- Class
- Class II
- Product code
- MML
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 MML? 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? (3)
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 |
|---|---|---|---|
| * | — | Gold Eyelid Implants Named without a submission number | |
| * | — | EyeClose External Eyelid Weights Named without a submission number | |
| * | — | External Series 1000 External Eyelid Weight (MedDev) Named without a submission number |
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.
How does its category compare?
All MML devicesMML Weights, Eyelid, External: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MML
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MML
Too few MML 510(k)s in any year since 2007 to give a median.
Recalls per year · MML
No recall names MML since 2007.
Adverse event reports per year · MML
1in 2022
MAUDE reports naming product code MML, 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 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Blink External Eyelid Weight are attached with an adhesive tape or gum to the outer surface of the upper eyelid. This weight acts by gravity to restore a functional blink mechanism to the patient who is afflicted with lagophthalmos. Usually the adhesive is changed daily after bathing.
The patient with lagophthalmos is unable to close the eyelid completely because of partial or complete paralysis to the facial nerve. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve. The condition of paralysis can be either permanent or transient.
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/K971245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971245: Blink External Eyelid Weight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971245
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026