510(k) Report

510(k) · Cleared

Cleared

Plastic Disposable Surgical Light Handle Cover

K915068510(k) TraditionalCleared Feb 6, 199290-day reviewClass II21 CFR 878.4580

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

American Medical Mfg., Inc. · FTA Light, Surgical, Accessories

Cleared on Feb 6, 1992 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Feb 6, 1992
Review
90 days
Class
Class II
Product code
FTA
Recalls
None
Predicates
0

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

Descendants, by year cleared 2014: 1 descendant cleared1990200020102020
  1. This deviceK915068 Plastic Disposable Surgical Light Handle CoverAmerican Medical Mfg., Inc. · 1992
  2. Descendant · cites it directly · 0 of its ownK142386 Operating Room Light Handle AdapterLitex Manufacturing, Inc. · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K142386Operating Room Light Handle AdapterLitex Manufacturing, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K915068Plastic Disposable Surgical Light Handle CoverAmerican Medical Mfg., Inc.1992—
+1K142386Operating Room Light Handle AdapterLitex Manufacturing, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K915068, 1992–2014Source: 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 FTA? 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 lists a 510(k) statement for it but has not posted the file, 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
K142386Operating Room Light Handle AdapterLitex Manufacturing, Inc.20140

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, K142386 (Litex Manufacturing, Inc., 2014) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FTA devices

FTA Light, Surgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTA

1in 2015

2008: 12010: 12012: 12014: 32015: 1
2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTA

61in 2014

2014: 61 days median
2007high 61 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTA

1in 2017

2007: 22017: 12026 (partial year): 1
2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · FTA

19in 2025

2009: 32013: 182014: 72015: 152016: 152017: 222018: 212019: 202020: 182021: 202022: 142023: 1052024: 292025: 19
2007high 105 (2023) · low 0 (2007)2025

MAUDE reports naming product code FTA, 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—20
20081—00
20090—03
20101—00
20110—00
20121—00
20130—018
201436107
20151—015
20160—015
20170—122
20180—021
20190—020
20200—018
20210—020
20220—014
20230—0105
20240—029
20250—019
20260—1—

More from American Medical Mfg., Inc.

6 FDA decisions under this applicant name. See the company

  • K982029Sharps Collection Container - Saf-T-ShellAmerican Medical Mfg., Inc. · 1999
  • K961454Ammi Magni-GuardAmerican Medical Mfg., Inc. · 1996
  • K915066Disposable Skin MarkerAmerican Medical Mfg., Inc. · 1992
  • K915064Disposable Cautery Abrasive PadAmerican Medical Mfg., Inc. · 1992
  • K915065I.V.Irrigation PoleAmerican Medical Mfg., Inc. · 1992

Recent decisions in FTA

The FTA category page

  • K150532Universal Light Handle Cover, Light Handle CoverKey Surgical, Inc. · 2015
  • K142386Operating Room Light Handle AdapterLitex Manufacturing, Inc. · 2014
  • K133554Surgical Light Handle CoverMicrotek Medical, Inc. an Ecolab Company · 2014
  • K133413Idss SLCBlack Diamond Video · 2014
  • K112133Oasys Surgical Light ControllerOasys Healthcare · 2012

https://510kreport.com/device/K915068 · printed Nov 4, 2026

Cite this page

510(k) Report. “K915068: Plastic Disposable Surgical Light Handle Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K915068

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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