510(k) · Cleared

Cleared

Contact Lens Ophthalmodynamometer

K052674510(k) TraditionalCleared May 24, 2006239-day reviewClass II21 CFR 886.1385

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

Meditron, GmbH · NYK Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)

Cleared on May 24, 2006 as substantially equivalent to K051103 (Haag-Streit USA, Inc., 2005) after a 239-day review. Its family tree reaches back 2 generations to 1994.

Decided: May 24, 2006
Review: 239 days
Class: Class II
Product code: NYK
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K943125 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK943125 Quadraspheric Fundus LensVolk Optical, Inc. · 1994
1 generation backK051103 Haag-Streit Contact Glasses Stery Cup, AccessoryHaag-Streit USA, Inc. · 2005
This deviceK052674 Contact Lens OphthalmodynamometerMeditron, GmbH · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K943125	Quadraspheric Fundus Lens	Volk Optical, Inc.	1994	—
−1	K051103	Haag-Streit Contact Glasses Stery Cup, Accessory	Haag-Streit USA, Inc.	2005	—
0 (this device)	K052674	Contact Lens Ophthalmodynamometer	Meditron, GmbH	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0

FIG. 1 — Lineage of K052674, 1994–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in NYK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K051103	Haag-Streit Contact Glasses Stery Cup, Accessory Summary page 2 …ctures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye. Predicate Device K051103 - Haag-Streit Contact Glasses manufactured by Haag-Streit USA Inc, Mason, Ohio. Voluntary Standards EN 60601-1 / IEC 60601-1, "M…	Haag-Streit USA, Inc.	2005	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
1 of the 4 ancestors has a recall of any class.

How does its category compare?

All NYK devices

NYK Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NYK

FDA has decided no NYK device since 2007.

Median 510(k) review, days · NYK

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

Recalls per year · NYK

No recall names NYK since 2007.

Adverse event reports per year · NYK

No MAUDE report names NYK since 2007.

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	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052674 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052674: Contact Lens Ophthalmodynamometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052674

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026