510(k) Report

510(k) · Cleared

Cleared

Lantos 3D Ear Scanner

K121326510(k) TraditionalCleared Jan 25, 2013268-day reviewClass I21 CFR 874.4770

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

Lantos Technologies · ERA Otoscope

Cleared on Jan 25, 2013 as substantially equivalent to K943916 (Welch Allyn, Inc., 1994) after a 268-day review. Its family tree reaches back 1 generation to 1994.

Decided
Jan 25, 2013
Review
268 days
Class
Class I
Product code
ERA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K943916 (1994). No later device cites it as a predicate yet.

K943916 · Videotoscope · Welch Allyn, Inc. · 1994199019952000200520102015
K943916 · Videotoscope · Welch Allyn, Inc. · 19940
  1. Root · 1 generation backK943916 VideotoscopeWelch Allyn, Inc. · 1994
  2. This deviceK121326 Lantos 3D Ear ScannerLantos Technologies · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K943916VideotoscopeWelch Allyn, Inc.1994—
0 (this device)K121326Lantos 3D Ear ScannerLantos Technologies2013—
FIG. 1 — Lineage of K121326, 1994–2013Source: 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 ERA? 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? (1)

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
*K943916Videotoscope
Summary page 1
…51 0(k) Numbers and Product Codes of equivalent devices: Welch Allyn Video Otoscope (Skaneateles Falls, NY) Welch Allyn Otoscope; K943916 - SE 08/25/1 994 Code: ERA; 874.7440 Device Description The device consists of a hand held scan…
Welch Allyn, Inc.1994—

Also cleared against K943916: 1 other device →

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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K943916.

How does its category compare?

All ERA devices

ERA Otoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · ERA

2in 2013

2011: 12013: 2
2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ERA

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

Recalls per year · ERA

No recall names ERA since 2007.

Adverse event reports per year · ERA

2in 2025

2014: 22019: 12021: 32022: 32023: 32024: 22025: 2
2007high 3 (2021) · low 0 (2007)2025

MAUDE reports naming product code ERA, 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
20111—00
20120—00
20132—00
20140—02
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—03
20220—03
20230—03
20240—02
20250—02
20260—0—

What is it indicated for?

The Lantos 3D Ear Scanner is intended for use by a trained hearing professional on patients 18 years of age and older presenting for inspection of the external ear canal.

The Lantos 3D Ear scanner:

* provides a magnified visual image for inspection of the external ear canal and tympanic membrane, and provides illumination of the ear canal for inspection and;

* includes an expanding membrane that can be inserted and conforms to the external ear canal when filled with an absorbing medium which enables the 3D scan and;

* records and presents to the hearing professional in an image file a topology measurement of the external ear canal

Indications for use as stated in the FDA summary.

Also cleared against K943916

1 other device cites the same predicate.

  • K123821Aio HD OtoscopeBlue Focus · 2013

Recent decisions in ERA

The ERA category page

  • K123821Aio HD OtoscopeBlue Focus · 2013
  • K110326Osram ItosOsram Sylvania, Inc. · 2011
  • K945264Optus OtoscopesOptus, Inc. · 1996
  • K955043Welch Allyn BI-OtoscopeWelch Allyn, Inc. · 1995
  • K952578Welch Ally OtoscopeWelch Allyn, Inc. · 1995

https://510kreport.com/device/K121326 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121326: Lantos 3D Ear Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121326

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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