510(k) · Cleared

Cleared

Orbscan (TM) Keratometer

K940647510(k) TraditionalCleared Jul 6, 1994141-day reviewClass I21 CFR 886.1350

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

Orbtek, Inc. · HLQ Keratoscope, Ac-Powered

Cleared on Jul 6, 1994 after a 141-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Jul 6, 1994
Review: 141 days
Class: Class I
Product code: HLQ
Recalls: None
Predicates: 0

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

This deviceK940647 Orbscan (TM) KeratometerOrbtek, Inc. · 1994
Descendant · cites it directly · 1 of its ownK984443 OrbscanTechnolas Perfect Vision GmbH · 1999
Descendant · 2 generations on · 0 of its ownK040913 Ngdi (Next Generation Diagnostic Instrument)Bausch & Lomb · 2004

Most influential descendants

Showing 2 of 2 · See all

K984443OrbscanTechnolas Perfect Vision GmbH · 1999 · cites it directly1descendant
K040913Ngdi (Next Generation Diagnostic Instrument)Bausch & Lomb · 2004 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K940647	Orbscan (TM) Keratometer	Orbtek, Inc.	1994	—
+1	K984443	Orbscan	Technolas Perfect Vision GmbH	1999	—
+2	K040913	Ngdi (Next Generation Diagnostic Instrument)	Bausch & Lomb	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2004	1	0

FIG. 1 — Lineage of K940647, 1994–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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? (2)

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

Number	Device	Applicant	Decided	Descendants
K984443	Orbscan	Technolas Perfect Vision GmbH	1999	1

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, K984443 (Technolas Perfect Vision GmbH, 1999) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HLQ devices

HLQ Keratoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HLQ

FDA has decided no HLQ device since 2007.

Median 510(k) review, days · HLQ

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

Recalls per year · HLQ

No recall names HLQ since 2007.

Adverse event reports per year · HLQ

1in 2017

2007high 1 (2017) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K940647 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940647: Orbscan (TM) Keratometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940647

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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