510(k) Report

510(k) · Cleared

Cleared

Trans-Oral Depth Gauge

K893415510(k) TraditionalCleared Jun 7, 198936-day reviewClass I21 CFR 888.4540

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

Ruggles Corp. · LYQ Accessories, Fixation, Spinal Intervertebral Body

Cleared on Jun 7, 1989 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 7, 1989
Review
36 days
Class
Class I
Product code
LYQ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K893415Source: 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.

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  • 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?

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 LYQ devices

LYQ Accessories, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYQ

FDA has decided no LYQ device since 2007.

Median 510(k) review, days · LYQ

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

Recalls per year · LYQ

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYQ

1in 2025

2013: 32018: 12025: 1
2007high 3 (2013) · low 0 (2007)2025

MAUDE reports naming product code LYQ, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—03
20140—00
20150—10
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—

More from Ruggles Corp.

5 FDA decisions under this applicant name. See the company

  • K903485Titanium MeshRuggles Corp. · 1991
  • K902818Multiple Nonpowered Neurosurgical InstrumentRuggles Corp. · 19901 recall
  • K902819Laminectomy RogeurRuggles Corp. · 1990
  • K902850Zeppelin InstrumentsRuggles Corp. · 1990

Recent decisions in LYQ

The LYQ category page

  • K883784TSRH Anterior Spinal Screws, Staples and End PlateWarsaw Orthopedic, Inc. · 1989
  • K882871Casf Drill Guide DG 170Terray Manufacturing, Inc. · 1988

https://510kreport.com/device/K893415 · printed Nov 6, 2026

Cite this page

510(k) Report. “K893415: Trans-Oral Depth Gauge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K893415

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