# K971465: National Medical Halthcare Custom Ophthalmic Kits or Trays

- Pathway: 510(k) (Traditional)
- Applicant: National Healthcare Mfg. Corp.
- Decided: Jun 4, 1997 after 43 days
- Product code: HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear))
- Device class: 1
- Regulation: 21 CFR 886.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K880961 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880961: Alcon Surgical Procedure Packs, Alcon Laboratories (1988) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K971465
Methodology: https://510kreport.com/methodology