510(k) Report

510(k) · Cleared

Cleared

OBER2 Monitor, Eye Movement (Ophthalmic)

K902954510(k) TraditionalCleared Aug 23, 199049-day reviewClass II21 CFR 884.1050

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

Permobil AB · HFC Aspirator, Endocervical

Cleared on Aug 23, 1990 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Aug 23, 1990
Review
49 days
Class
Class II
Product code
HFC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2016: 1 descendant cleared2004: 1 descendant cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK902954 OBER2 Monitor, Eye Movement (Ophthalmic)Permobil AB · 1990
  2. Descendant · cites it directly · 1 of its ownK152890 Saccadometer Plus, Saccadometer AdvancedOber Consulting Sp. Z.O.O. · 2016
  3. Descendant · 2 generations on · 0 of its ownK222484 RetitrackC. Light Technologies, Inc. · 2023
  4. Descendant · cites it directly · 0 of its ownK033949 Varilux Visionprint System (VPS)Essilor Intl. · 2004

Most influential descendants

Showing 3 of 3 · See all
  • K152890Saccadometer Plus, Saccadometer AdvancedOber Consulting Sp. Z.O.O. · 2016 · cites it directly1descendant
  • K222484RetitrackC. Light Technologies, Inc. · 2023 · 2 generations on0descendants
  • K033949Varilux Visionprint System (VPS)Essilor Intl. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K902954OBER2 Monitor, Eye Movement (Ophthalmic)Permobil AB1990—
+1K152890Saccadometer Plus, Saccadometer AdvancedOber Consulting Sp. Z.O.O.2016—
+2K222484RetitrackC. Light Technologies, Inc.2023—
+1K033949Varilux Visionprint System (VPS)Essilor Intl.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201610
202310
FIG. 1 — Lineage of K902954, 1990–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 HFC? 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
Get a 510(k) Report

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? (3)

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

NumberDeviceApplicantDecidedDescendants
K152890Saccadometer Plus, Saccadometer AdvancedOber Consulting Sp. Z.O.O.20161
K033949Varilux Visionprint System (VPS)Essilor Intl.20040

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, K152890 (Ober Consulting Sp. Z.O.O., 2016) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HFC devices

HFC Aspirator, Endocervical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HFC

FDA has decided no HFC device since 2007.

Median 510(k) review, days · HFC

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

Recalls per year · HFC

No recall names HFC since 2007.

Adverse event reports per year · HFC

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code HFC, 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—00
20110—00
20120—00
20130—00
20140—01
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Permobil AB

15 FDA decisions under this applicant name. See the company

  • K190682Explorer MiniPermobil AB · 2020
  • K191874F5 Corpus VSPermobil AB · 2019
  • K143180F3Permobil AB · 2015
  • K143014F5Permobil AB · 2015
  • K123290M300 & M400Permobil AB · 20133 recalls

Recent decisions in HFC

The HFC category page

  • K974032Rocket Mucus Sampler Syringe, Sterile, Rocket Mucus Sampler Syringe, Clinically AspiratorA & A Medical, Inc. · 1997
  • K960263Cervical Mucous Aspiration CatheterCook Urological, Inc. · 1996
  • K954903Pedi Vaginal AspiratorCook Urological, Inc. · 1996
  • K954102SelectmucusSelect Medical Systems, Inc. · 1995
  • K902242Endocervical AspiratorInnovative Medical Products, Inc. · 1990

https://510kreport.com/device/K902954 · printed Nov 6, 2026

Cite this page

510(k) Report. “K902954: OBER2 Monitor, Eye Movement (Ophthalmic).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902954

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026