510(k) Report

510(k) · Cleared

Cleared

The Orthoranger II Electronic Goniometer

K884611510(k) TraditionalCleared Jan 31, 198988-day reviewClass I21 CFR 888.1500

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

Medical Instruments Technology, Inc. · KQX Goniometer, Ac-Powered

Cleared on Jan 31, 1989 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 31, 1989
Review
88 days
Class
Class I
Product code
KQX
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K884611Source: FDA 510(k) database · 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.

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

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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?

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.

How does its category compare?

All KQX devices

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

FDA decisions per year · KQX

FDA has decided no KQX device since 2007.

Median 510(k) review, days · KQX

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

Recalls per year · KQX

No recall names KQX since 2007.

Adverse event reports per year · KQX

No MAUDE report names KQX since 2007.

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

More from Medical Instruments Technology, Inc.

5 FDA decisions under this applicant name. See the company

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  • K012640Electrosurgical Cutting and Coagulation Accessories, Electrosurgical WandsMedical Instruments Technology, Inc. · 20021 recall
  • K012624Reprocessed Arthroscopic Blades, Arthroscopic Shavers, Shaver Blade, Blade, Limited Reuse Blade…Medical Instruments Technology, Inc. · 2001
  • K012632Tourniquet Cuff; Pneumatic TourniquetMedical Instruments Technology, Inc. · 2001

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https://510kreport.com/device/K884611 · printed Nov 4, 2026

Cite this page

510(k) Report. “K884611: The Orthoranger II Electronic Goniometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K884611

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