# K843646: Steinway Micro-Kerato-Trephine

- Pathway: 510(k) (Traditional)
- Applicant: Steinway Instrument Co., Inc.
- Decided: Jan 3, 1985 after 108 days
- Product code: HRH (Trephine, Manual, Ophthalmic)
- Device class: 1
- Regulation: 21 CFR 886.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K981155: Flapmaker Disposable Microkeratome (1998), 4 descendants of its own
- K990900: Microkeratome, Model MK-2000 (1999), 2 descendants of its own
- K052891: Horizon Epikeratome Disposable Microkeratome System (2006), 0 descendants of its own
- K032297: Disposable N-PE Mickrokeratome Blades (2003), 0 descendants of its own
- K022205: Disposable N-PE Microkeratome Blades (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K843646
Methodology: https://510kreport.com/methodology