510(k) Report

510(k) · Cleared

Cleared

Deemed MSS -- Microscope Support System

K920689510(k) TraditionalCleared Nov 12, 1993637-day reviewClass I21 CFR 878.4700

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

Deemed, Inc. · FSO Microscope, Surgical, General & Plastic Surgery

Cleared on Nov 12, 1993 after a 637-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Nov 12, 1993
Review
637 days
Class
Class I
Product code
FSO
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1998: 1 descendant cleared1999: 1 descendant cleared1990200020102020
  1. This deviceK920689 Deemed MSS -- Microscope Support SystemDeemed, Inc. · 1993
  2. Descendant · cites it directly · 2 of its ownK961639 Leksell Image Guidance Surgical System (Ligs)Elekta Instrument AB · 1996
  3. Descendant · 2 generations on · 1 of its ownK973684 Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB · 1998
  4. Descendant · 3 generations on · 0 of its ownK992882 Leksell Image Guidance Surgical System, View Scope…Elekta Instrument AB · 1999

Most influential descendants

Showing 3 of 3 · See all
  • K961639Leksell Image Guidance Surgical System (Ligs)Elekta Instrument AB · 1996 · cites it directly2descendants
  • K973684Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB · 1998 · 2 generations on1descendant
  • K992882Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta InsightElekta Instrument AB · 1999 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920689Deemed MSS -- Microscope Support SystemDeemed, Inc.1993—
+1K961639Leksell Image Guidance Surgical System (Ligs)Elekta Instrument AB1996—
+2K973684Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB1998—
+3K992882Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta InsightElekta Instrument AB1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
199910
FIG. 1 — Lineage of K920689, 1993–1999Source: 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 FSO? 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K961639Leksell Image Guidance Surgical System (Ligs)Elekta Instrument AB19962

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, K961639 (Elekta Instrument AB, 1996) has gone furthest, with 2 descendants of its own.

How does its category compare?

All FSO devices

FSO Microscope, Surgical, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FSO

FDA has decided no FSO device since 2007.

Median 510(k) review, days · FSO

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

Recalls per year · FSO

1in 2023

2010: 22012: 12021: 12023: 1
2007high 2 (2010) · low 0 (2007)2026

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

Adverse event reports per year · FSO

17in 2025

2010: 22011: 12012: 22013: 22014: 72015: 102016: 122017: 142018: 112019: 122020: 72021: 192022: 52023: 172024: 152025: 17
2007high 19 (2021) · low 0 (2007)2025

MAUDE reports naming product code FSO, 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—22
20110—01
20120—12
20130—02
20140—07
20150—010
20160—012
20170—014
20180—011
20190—012
20200—07
20210—119
20220—05
20230—117
20240—015
20250—017
20260—0—

Recent decisions in FSO

The FSO category page

  • K942304MicroflexMoeller Microsurgical, Inc. · 1994
  • K941399Operating Microscope AA OM 10Appasamy Associates (U.S.A.), Inc. · 1994
  • K926288Som 6VI (Surgical Operating Microscope)Jedmed Instrument Co. · 1993
  • K931303Woodlyn Operation MicroscopeWoodlyn, Inc. · 1993
  • K926513Moller-Wedel Operating MicroscopeMoeller Microsurgical, Inc. · 1993

https://510kreport.com/device/K920689 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920689: Deemed MSS -- Microscope Support System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920689

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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