510(k) Report

510(k) · Cleared

Cleared

Octopus 500/500E

K841099510(k) TraditionalCleared Jun 19, 198499-day reviewClass I21 CFR 886.1605

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

Cilco, Inc. · HPT Perimeter, Automatic, Ac-Powered

Cleared on Jun 19, 1984 after a 99-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Jun 19, 1984
Review
99 days
Class
Class I
Product code
HPT
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared2009: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared19801990200020102020
  1. This deviceK841099 Octopus 500/500ECilco, Inc. · 1984
  2. Descendant · cites it directly · 5 of its ownK050350 The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview…Notal Vision, Inc. · 2005
  3. Descendant · 2 generations on · 4 of its ownK091579 Foresee HomeNotal Vision, Ltd. · 2009
  4. Descendant · 3 generations on · 3 of its ownK121738 Myvisiontrack (TM)Vital Art and Science Incorporated · 2013
  5. Descendant · 4 generations on · 2 of its ownK143211 myVision Track Model 005Vital Art and Science Incorporated · 2015
  6. Descendant · 5 generations on · 1 of its ownK180895 AlleyeOculocare Medical AG · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12009: 12013: 12015: 12018: 12022: 1
2005high 1 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all
  • K050350The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP)Notal Vision, Inc. · 2005 · cites it directly5descendants
  • K091579Foresee HomeNotal Vision, Ltd. · 2009 · 2 generations on4descendants
  • K121738Myvisiontrack (TM)Vital Art and Science Incorporated · 2013 · 3 generations on3descendants
  • K143211myVision Track Model 005Vital Art and Science Incorporated · 2015 · 4 generations on2descendants
  • K180895AlleyeOculocare Medical AG · 2018 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K841099Octopus 500/500ECilco, Inc.1984—
+1K050350The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP)Notal Vision, Inc.2005—
+2K091579Foresee HomeNotal Vision, Ltd.2009—
+3K121738Myvisiontrack (TM)Vital Art and Science Incorporated2013—
+4K143211myVision Track Model 005Vital Art and Science Incorporated2015—
+5K180895AlleyeOculocare Medical AG2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200910
201310
201510
201810
202210
FIG. 1 — Lineage of K841099, 1984–2022Source: 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 HPT? 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K050350The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP)Notal Vision, Inc.20055

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, K050350 (Notal Vision, Inc., 2005) has gone furthest, with 5 descendants of its own.

How does its category compare?

All HPT devices

HPT Perimeter, Automatic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HPT

2in 2010

2007: 12009: 12010: 2
2007high 2 (2010) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HPT

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

Recalls per year · HPT

No recall names HPT since 2007.

Adverse event reports per year · HPT

1in 2023

2018: 12022: 12023: 1
2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code HPT, 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—00
20080—00
20091—00
20102—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—01
20230—01
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K841099: Octopus 500/500E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K841099

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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