510(k) Report

510(k) · Cleared

Cleared

MVS Fiberoptic Lightpipe

K870942510(k) TraditionalCleared Apr 3, 198725-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

Advanced Surgical Products, Inc. · FST Light, Surgical, Fiberoptic

Cleared on Apr 3, 1987 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.

Decided
Apr 3, 1987
Review
25 days
Class
Class II
Product code
FST
Recalls
None
Predicates
0

9 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 2 descendants cleared2005: 1 descendant cleared2015: 1 descendant cleared2012: 1 descendant cleared2019: 2 descendants cleared2014: 1 descendant cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK870942 MVS Fiberoptic LightpipeAdvanced Surgical Products, Inc. · 1987
  2. Descendant · cites it directly · 7 of its ownK982462 Fiber Optic Endoillumination ProbeMicrovision, Inc. · 1998
  3. Descendant · 2 generations on · 6 of its ownK050807 20G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 2005
  4. Descendant · 3 generations on · 5 of its ownK121187 Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC · 2012
  5. Descendant · 3 generations on · 2 of its ownK142830 Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015
  6. Descendant · 4 generations on · 1 of its ownK191846 MAXReach Laser ProbeVortex Surgical, Inc. · 2019

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

1998: 22005: 12012: 12014: 12015: 12019: 22022: 1
1998high 2 (1998) · low 0 (1999)2026

Most influential descendants

Showing 5 of 9 · See all
  • K982462Fiber Optic Endoillumination ProbeMicrovision, Inc. · 1998 · cites it directly7descendants
  • K05080720G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 2005 · 2 generations on6descendants
  • K121187Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC · 2012 · 3 generations on5descendants
  • K142830Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015 · 3 generations on2descendants
  • K191846MAXReach Laser ProbeVortex Surgical, Inc. · 2019 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K870942MVS Fiberoptic LightpipeAdvanced Surgical Products, Inc.1987—
+1K982462Fiber Optic Endoillumination ProbeMicrovision, Inc.1998—
+2K05080720G Sma Laser Fiber, Model LF100Ophthalmed, LLC2005—
+3K121187Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC2012—
+3K142830Ophthalmed Bending Laser ProbesOphthalmed, LLC2015—
+4K191846MAXReach Laser ProbeVortex Surgical, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
200510
201210
201410
201510
201920
202210
FIG. 1 — Lineage of K870942, 1987–2022Source: 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 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
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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? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K982462Fiber Optic Endoillumination ProbeMicrovision, Inc.19987
K980636Fiber Optic Endoillumination ProbeDutch Ophthalmic USA, Inc.19980

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, K982462 (Microvision, Inc., 1998) has gone furthest, with 7 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.

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—
Cite this page

510(k) Report. “K870942: MVS Fiberoptic Lightpipe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K870942

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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