510(k) Report

510(k) · Cleared

Cleared

Lite Wand II

K080962510(k) TraditionalCleared Jun 25, 200882-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

Thompson Surgical Instruments, Inc. · FST Light, Surgical, Fiberoptic

Cleared on Jun 25, 2008 after an 82-day review. The FDA summary names no predicate by number. 1 later device descends from it.

Decided
Jun 25, 2008
Review
82 days
Class
Class II
Product code
FST
Recalls
None
Predicates
0

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

Descendants, by year cleared 2009: 1 descendant cleared20052010201520202025
  1. This deviceK080962 Lite Wand IIThompson Surgical Instruments, Inc. · 2008
  2. Descendant · cites it directly · 0 of its ownK090070 Invuity Britefield Mcculloch Retractor SystemInvuity, Inc. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K090070Invuity Britefield Mcculloch Retractor SystemInvuity, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K080962Lite Wand IIThompson Surgical Instruments, Inc.2008—
+1K090070Invuity Britefield Mcculloch Retractor SystemInvuity, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K080962, 2008–2009Source: 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), 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 FST? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FST device

  1. #1 K200874 TruView Light Cable, TruView Lateral Retractor…score -0.4 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K090070Invuity Britefield Mcculloch Retractor SystemInvuity, Inc.20090

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, K090070 (Invuity, Inc., 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FST devices

FST Light, Surgical, Fiberoptic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · FST

1in 2020

2007: 12008: 22009: 32010: 52012: 32014: 12020: 1
2007high 5 (2010) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FST

59in 2012

2009: 100 days median2010: 90 days median2012: 59 days median
2007high 100 (2009) · low 59 (2012)2026

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

Recalls per year · FST

1in 2014

2011: 102014: 1
2007high 10 (2011) · low 0 (2007)2026

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

Adverse event reports per year · FST

27in 2025

2007: 32008: 22009: 42010: 32011: 72012: 142013: 92014: 132015: 142016: 152017: 202018: 122019: 292020: 332021: 202022: 112023: 112024: 402025: 27
2007high 40 (2024) · low 2 (2008)2025

MAUDE reports naming product code FST, 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
20071—03
20082—02
2009310004
201059003
20110—107
2012359014
20130—09
20141—113
20150—014
20160—015
20170—020
20180—012
20190—029
20201—033
20210—020
20220—011
20230—011
20240—040
20250—027
20260—0—

What is it indicated for?

The Thompson Surgical Instruments, Inc. Lite Wand II intended as a task light for surgical procedures. It is designed to be used in conjunction with a retractor system which it can attach to through the use of a Cam Joint. The Lite Wand II is designed to provide visible illumination of the surgical field or the patient through a Halogen light source only. It is intended to be used with ACMII, Storz, Wolf, or Olympus connector cables. The Lite Wand II is intended to be used by surgeons and medical care practitioners in a surgical setting.

Indications for use as stated in the FDA summary.

More from Thompson Surgical Instruments, Inc.

2 FDA decisions under this applicant name. See the company

  • K210615Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)Thompson Surgical Instruments, Inc. · 2022

Recent decisions in FST

The FST category page

  • K200874TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal EndInnovasis, Inc. · 2020
  • K141330Endo-CordEnroxtech, Inc. · 2014
  • K122637Lite Decompression System- Light Cable Model 48089999Stryker Spine · 2012
  • K113697Eigr Surgical Illumination SystemInvuity, Inc. · 2012
  • K113330CablecapSensormed · 2012

https://510kreport.com/device/K080962 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080962: Lite Wand II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080962

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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