510(k) · Cleared
ClearedNational Medical Halthcare Custom Ophthalmic Kits or Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
National Healthcare Mfg. Corp. · HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Cleared on Jun 4, 1997 as substantially equivalent to K880961 (Alcon Laboratories, 1988) after a 43-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Jun 4, 1997
- Review
- 43 days
- Class
- Class I
- Product code
- HOY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880961 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK880961 Alcon Surgical Procedure PacksAlcon Laboratories · 1988 · Recalled
- This deviceK971465 National Medical Halthcare Custom Ophthalmic Kits or TraysNational Healthcare Mfg. Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880961 | Alcon Surgical Procedure Packs | Alcon Laboratories | 1988 | 14 |
| 0 (this device) | K971465 | National Medical Halthcare Custom Ophthalmic Kits or Trays | National Healthcare Mfg. Corp. | 1997 | — |
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 HOY? 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 |
|---|---|---|---|
| * | K880961 | Alcon Surgical Procedure PacksSummary page 2…hthalmic packs . are substantially identical in materals. packaging, sterilization, and intended use to the Alcon Surgical Custom Ophthalmic Trays legally marketed under K880961. Description of the Subject Device: The National Healthcare Manufacturing custom ophthalmic procedure trays or kits are sterile… | 1988 |
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 a recall.
How does its category compare?
All HOY devicesHOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HOY
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HOY
Too few HOY 510(k)s in any year since 2007 to give a median.
Recalls per year · HOY
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HOY
2in 2025
MAUDE reports naming product code HOY, 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 | 4 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
These kits are a convenience assemblage of sterile, disposable, legally
marketed medical devices intended for use by trained physicians for
ophthalmic surgical procedures. National Healthcare Manufacturing
Corporation does not cause or promote new intended uses for the devices
within these kits.
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/K971465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971465: National Medical Halthcare Custom Ophthalmic Kits or Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971465
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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