510(k) Report

510(k) · Cleared

Cleared

Qualtex Light Handle and Light Handle Cover

K911369510(k) TraditionalCleared May 13, 199146-day reviewClass I21 CFR 878.4800

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

Deroyal Industries, Inc. · MDM Instrument, Manual, Surgical, General Use

Cleared on May 13, 1991 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
May 13, 1991
Review
46 days
Class
Class I
Product code
MDM
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared1990200020102020
  1. This deviceK911369 Qualtex Light Handle and Light Handle CoverDeroyal Industries, Inc. · 1991
  2. Descendant · cites it directly · 0 of its ownK053321 Light Guard Light Handle and Light Handle CoverXodus Medical, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K053321Light Guard Light Handle and Light Handle CoverXodus Medical, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K911369Qualtex Light Handle and Light Handle CoverDeroyal Industries, Inc.1991—
+1K053321Light Guard Light Handle and Light Handle CoverXodus Medical, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K911369, 1991–2006Source: 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.

Planning a device in MDM? 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?

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

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K053321Light Guard Light Handle and Light Handle CoverXodus Medical, Inc.20060

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, K053321 (Xodus Medical, Inc., 2006) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MDM devices

MDM Instrument, Manual, Surgical, General Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MDM

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MDM

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

Recalls per year · MDM

1in 2024

2009: 12010: 172011: 12014: 12017: 22021: 12022: 22024: 12026 (partial year): 1
2007high 17 (2010) · low 0 (2007)2026

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

Adverse event reports per year · MDM

318in 2025

2007: 252008: 502009: 1312010: 492011: 522012: 532013: 742014: 662015: 1612016: 3172017: 1872018: 4002019: 2812020: 2452021: 2272022: 1822023: 2092024: 5072025: 318
2007high 507 (2024) · low 25 (2007)2025

MAUDE reports naming product code MDM, 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—025
20081—050
20090—1131
20100—1749
20110—152
20120—053
20130—074
20140—166
20150—0161
20160—0317
20170—2187
20180—0400
20190—0281
20200—0245
20210—1227
20220—2182
20230—0209
20240—1507
20250—0318
20260—1—

More from Deroyal Industries, Inc.

91 FDA decisions under this applicant name. See the company

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  • K200631DeRoyal Temperature Monitoring ProbeDeroyal Industries, Inc. · 2020
  • K200757Foley Catheter with Temperature SensorDeroyal Industries, Inc. · 2020
  • K193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French…Deroyal Industries, Inc. · 2020

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The MDM category page

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https://510kreport.com/device/K911369 · printed Nov 6, 2026

Cite this page

510(k) Report. “K911369: Qualtex Light Handle and Light Handle Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911369

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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