510(k) Report

510(k) · Cleared

Cleared

Aio HD Otoscope

K123821510(k) TraditionalCleared May 17, 2013156-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

Blue Focus · ERA Otoscope

Cleared on May 17, 2013 as substantially equivalent to K943916 (Welch Allyn, Inc., 1994) and 1 other predicate after a 156-day review. Its family tree reaches back 1 generation to 1991.

Decided
May 17, 2013
Review
156 days
Class
Class I
Product code
ERA
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K904802 (1991). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestorK904802 · Video Otoscope · Jedmed Instrument Co. · 1991199019952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor K904802 · Video Otoscope · Jedmed Instrument Co. · 19910
  1. Root · 1 generation backK904802 Video OtoscopeJedmed Instrument Co. · 1991
  2. This deviceK123821 Aio HD OtoscopeBlue Focus · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K904802Video OtoscopeJedmed Instrument Co.1991—
0 (this device)K123821Aio HD OtoscopeBlue Focus2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
FIG. 1 — Lineage of K123821, 1991–2013Source: 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.

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  • 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? (3)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK031853Dr.Camscope Video Otoscope
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
*K943916Videotoscope
Summary page 1
…510 (k) Numbers and Product Codes of equivalent devices: Dr.Camscope Video Otoscope: 1<031 853, / Code: ERA 874.4770 Welch Allyn Video Otoscope: k943916 / Code: ERA 874.4770 Jed Med Instrument Video Otoscope: k<904802 / Code: ERA 874.4770 Device Description A1…
Welch Allyn, Inc.1994—
*K904802Video Otoscope
Summary page 1
…scope Video Otoscope: 1<031 853, / Code: ERA 874.4770 Welch Allyn Video Otoscope: k943916 / Code: ERA 874.4770 Jed Med Instrument Video Otoscope: k<904802 / Code: ERA 874.4770 Device Description A10 camera system consists of the camera hand probe, main storage unit and…
Jedmed Instrument Co.1991—

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?

  • None of the 2 ancestors has a 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?

MIO RD otoscope is used to provide images of the ear canal and tympanic membrane. The MIO HID otoscope can be used to allow a physician a clear and focused view of the ear canal or tympanic membrane on a computer or monitor screen.

Indications for use as stated in the FDA summary.

Also cleared against K943916

1 other device cites the same predicate.

  • K121326Lantos 3D Ear ScannerLantos Technologies · 2013

Recent decisions in ERA

The ERA category page

  • K121326Lantos 3D Ear ScannerLantos Technologies · 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/K123821 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123821: Aio HD Otoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123821

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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