510(k) Report

510(k) · Cleared

Cleared

Steinway Micro-Kerato-Trephine

K843646510(k) TraditionalCleared Jan 3, 1985108-day reviewClass I21 CFR 886.4350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Steinway Instrument Co., Inc. · HRH Trephine, Manual, Ophthalmic

Cleared on Jan 3, 1985 after a 108-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Jan 3, 1985
Review
108 days
Class
Class I
Product code
HRH
Recalls
None
Predicates
0

5 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2006: 1 descendant cleared1999: 1 descendant cleared2003: 1 descendant cleared2002: 1 descendant cleared1990200020102020
  1. This deviceK843646 Steinway Micro-Kerato-TrephineSteinway Instrument Co., Inc. · 1985
  2. Descendant · cites it directly · 4 of its ownK981155 Flapmaker Disposable MicrokeratomeHawken Industries · 1998
  3. Descendant · 2 generations on · 2 of its ownK990900 Microkeratome, Model MK-2000Nidek, Inc. · 1999
  4. Descendant · 2 generations on · 0 of its ownK052891 Horizon Epikeratome Disposable Microkeratome SystemHawken Industries · 2006
  5. Descendant · 3 generations on · 0 of its ownK032297 Disposable N-PE Mickrokeratome BladesOasis Medical, Inc. · 2003
  6. Descendant · 3 generations on · 0 of its ownK022205 Disposable N-PE Microkeratome BladesOasis Medical, Inc. · 2002

Most influential descendants

Showing 5 of 5 · See all
  • K981155Flapmaker Disposable MicrokeratomeHawken Industries · 1998 · cites it directly4descendants
  • K990900Microkeratome, Model MK-2000Nidek, Inc. · 1999 · 2 generations on2descendants
  • K052891Horizon Epikeratome Disposable Microkeratome SystemHawken Industries · 2006 · 2 generations on0descendants
  • K032297Disposable N-PE Mickrokeratome BladesOasis Medical, Inc. · 2003 · 3 generations on0descendants
  • K022205Disposable N-PE Microkeratome BladesOasis Medical, Inc. · 2002 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K843646Steinway Micro-Kerato-TrephineSteinway Instrument Co., Inc.1985—
+1K981155Flapmaker Disposable MicrokeratomeHawken Industries1998—
+2K990900Microkeratome, Model MK-2000Nidek, Inc.1999—
+2K052891Horizon Epikeratome Disposable Microkeratome SystemHawken Industries2006—
+3K032297Disposable N-PE Mickrokeratome BladesOasis Medical, Inc.2003—
+3K022205Disposable N-PE Microkeratome BladesOasis Medical, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200210
200310
200610
FIG. 1 — Lineage of K843646, 1985–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981155Flapmaker Disposable MicrokeratomeHawken Industries19984

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?

  • Of its descendants, K981155 (Hawken Industries, 1998) has gone furthest, with 4 descendants of its own.

How does its category compare?

All HRH devices

HRH Trephine, Manual, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRH

FDA has decided no HRH device since 2007.

Median 510(k) review, days · HRH

Too few HRH 510(k)s in any year since 2007 to give a median.

Recalls per year · HRH

No recall names HRH since 2007.

Adverse event reports per year · HRH

2in 2023

2007: 12009: 12010: 42011: 12013: 12020: 12022: 12023: 2
2007high 4 (2010) · low 0 (2008)2025

MAUDE reports naming product code HRH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—00
20090—01
20100—04
20110—01
20120—00
20130—01
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—01
20210—00
20220—01
20230—02
20240—00
20250—00
20260—0—

Recent decisions in HRH

The HRH category page

  • K022843Gayheart Corneal Excision DeviceStephens Instruments · 2002
  • K931792ArthroscopeIntramed Laboratories, Inc. · 1994
  • K873918Head & Chin RestsRichmond Products, Inc. · 1987
  • K864520Barron Rotary Blade Trephine Using Hessburg-BarronPrecision Instruments, Inc. · 1987
  • K862524Deknatel (R) TrephineDeknatel, Inc. · 1986

https://510kreport.com/device/K843646 · printed Nov 6, 2026

Cite this page

510(k) Report. “K843646: Steinway Micro-Kerato-Trephine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K843646

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026