510(k) Report

510(k) · Cleared

Cleared

Invuity Britefield Mcculloch Retractor System

K090070510(k) TraditionalCleared Apr 22, 2009100-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

Invuity, Inc. · FST Light, Surgical, Fiberoptic

Cleared on Apr 22, 2009 as substantially equivalent to K080962 (Thompson Surgical Instruments, Inc., 2008) and 3 other predicates after a 100-day review. Its family tree reaches back 2 generations to 2000.

Decided
Apr 22, 2009
Review
100 days
Class
Class II
Product code
FST
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K002931 (2000). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 2 other ancestors2004: 2 other ancestorsK002931 · Metrx System · Medtronic Sofamor Danek, Inc. · 2000K043602 · Quadrant Retractor System · Medtronic Sofamor Danek · 2005200020022004200620082010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor K043602 · Quadrant Retractor System · Medtronic Sofamor Danek · 2005K002931 · Metrx System · Medtronic Sofamor Danek, Inc. · 20000
  1. Root · 2 generations backK002931 Metrx SystemMedtronic Sofamor Danek, Inc. · 2000
  2. 1 generation backK043602 Quadrant Retractor SystemMedtronic Sofamor Danek · 2005
  3. This deviceK090070 Invuity Britefield Mcculloch Retractor SystemInvuity, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K002931Metrx SystemMedtronic Sofamor Danek, Inc.2000—
−1K043602Quadrant Retractor SystemMedtronic Sofamor Danek2005—
0 (this device)K090070Invuity Britefield Mcculloch Retractor SystemInvuity, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200420
200820
FIG. 1 — Lineage of K090070, 2000–2009Source: 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? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K080962Lite Wand II
Summary page 2
…, Inc. believes that the Invuity BriteField T M McCulloch Retractor System is substantially equivalent to the following predicate devices: * Thompson Lite Wand II, K080962 * Medtronic MAST Quadrant Retractor System, K043602 * Zimmer MIS Light, K080367 * NuVasive MaXcess Light Guide,…
Thompson Surgical Instruments, Inc.2008—
*K043602Quadrant Retractor System
Summary page 2
…Retractor System is substantially equivalent to the following predicate devices: * Thompson Lite Wand II, K080962 * Medtronic MAST Quadrant Retractor System, K043602 * Zimmer MIS Light, K080367 * NuVasive MaXcess Light Guide, K042034 INTENDED USE The Invuity BriteField McCulloch Re…
Medtronic Sofamor Danek2005—
*K080367Zimmer Mis Light
Summary page 2
…equivalent to the following predicate devices: * Thompson Lite Wand II, K080962 * Medtronic MAST Quadrant Retractor System, K043602 * Zimmer MIS Light, K080367 * NuVasive MaXcess Light Guide, K042034 INTENDED USE The Invuity BriteField McCulloch Retractor System is intended to prov…
Zimmer Spine, Inc.2008—
*K042034Nuvasive Maxcess Light Guide
Summary page 2
…* Thompson Lite Wand II, K080962 * Medtronic MAST Quadrant Retractor System, K043602 * Zimmer MIS Light, K080367 * NuVasive MaXcess Light Guide, K042034 INTENDED USE The Invuity BriteField McCulloch Retractor System is intended to provide surgical site illumination from a high int…
Nuvasive, Inc.2004—

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.

What does this lineage say?

  • The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
  • None of the 6 ancestors has a recall.

How does its category compare?

All FST devices

FST Light, Surgical, Fiberoptic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Invuity BriteField McCulloch Retractor System is intended to provide surgical site illumination from a high intensity light source,

Indications for use as stated in the FDA summary.

More from Invuity, Inc.

4 FDA decisions under this applicant name. See the company

  • K191583PhotonBlade with Smoke EvacuationInvuity, Inc. · 2020
  • K162053PhotonBladeInvuity, Inc. · 20161 recall
  • K113697Eigr Surgical Illumination SystemInvuity, Inc. · 2012

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/K090070 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090070: Invuity Britefield Mcculloch Retractor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090070

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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