# K940647: Orbscan (TM) Keratometer

- Pathway: 510(k) (Traditional)
- Applicant: Orbtek, Inc.
- Decided: Jul 6, 1994 after 141 days
- Product code: HLQ (Keratoscope, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.1350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K984443: Orbscan (1999), 1 descendant of its own
- K040913: Ngdi (Next Generation Diagnostic Instrument) (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K940647
Methodology: https://510kreport.com/methodology