510(k) Report

510(k) · Cleared

Cleared

Otoview Endoscopy System

K934432510(k) TraditionalCleared Apr 25, 1994224-day reviewClass I21 CFR 874.1080

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

Smith & Nephew Richards, Inc. · EWA Set, Audiometer Calibration

Cleared on Apr 25, 1994 after a 224-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Apr 25, 1994
Review
224 days
Class
Class I
Product code
EWA
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared1999: 2 descendants cleared2009: 1 descendant cleared2008: 1 descendant cleared1990200020102020
  1. This deviceK934432 Otoview Endoscopy SystemSmith & Nephew Richards, Inc. · 1994
  2. Descendant · cites it directly · 4 of its ownK962255 Clarus Murphypen Endoscope (2127-XXX)Clarus Medical Systems, Inc. · 1996
  3. Descendant · 2 generations on · 2 of its ownK991377 Omnisonics Flexible Fiber Optic Endoscope and CouplerOmnisonics Medical Technologies · 1999
  4. Descendant · 2 generations on · 0 of its ownK082038 Clarus Video Airway Endoscope, Models 30000-V and 30003-VClarus Medical, LLC · 2009
  5. Descendant · 3 generations on · 0 of its ownK080780 Anchorage Scope, Model 000003Epitek, Inc. · 2008
  6. Descendant · 3 generations on · 0 of its ownK993445 Omnisonic Endoscopic DeflectorOmnisonics Medical Technologies · 1999

Most influential descendants

Showing 5 of 5 · See all
  • K962255Clarus Murphypen Endoscope (2127-XXX)Clarus Medical Systems, Inc. · 1996 · cites it directly4descendants
  • K991377Omnisonics Flexible Fiber Optic Endoscope and CouplerOmnisonics Medical Technologies · 1999 · 2 generations on2descendants
  • K082038Clarus Video Airway Endoscope, Models 30000-V and 30003-VClarus Medical, LLC · 2009 · 2 generations on0descendants
  • K080780Anchorage Scope, Model 000003Epitek, Inc. · 2008 · 3 generations on0descendants
  • K993445Omnisonic Endoscopic DeflectorOmnisonics Medical Technologies · 1999 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934432Otoview Endoscopy SystemSmith & Nephew Richards, Inc.1994—
+1K962255Clarus Murphypen Endoscope (2127-XXX)Clarus Medical Systems, Inc.1996—
+2K991377Omnisonics Flexible Fiber Optic Endoscope and CouplerOmnisonics Medical Technologies1999—
+2K082038Clarus Video Airway Endoscope, Models 30000-V and 30003-VClarus Medical, LLC2009—
+3K080780Anchorage Scope, Model 000003Epitek, Inc.2008—
+3K993445Omnisonic Endoscopic DeflectorOmnisonics Medical Technologies1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199920
200810
200910
FIG. 1 — Lineage of K934432, 1994–2009Source: 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 EWA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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? (5)

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

NumberDeviceApplicantDecidedDescendants
K962255Clarus Murphypen Endoscope (2127-XXX)Clarus Medical Systems, Inc.19964

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, K962255 (Clarus Medical Systems, Inc., 1996) has gone furthest, with 4 descendants of its own.

How does its category compare?

All EWA devices

EWA Set, Audiometer Calibration: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EWA

FDA has decided no EWA device since 2007.

Median 510(k) review, days · EWA

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

Recalls per year · EWA

No recall names EWA since 2007.

Adverse event reports per year · EWA

No MAUDE report names EWA since 2007.

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—00
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 Smith & Nephew Richards, Inc.

93 FDA decisions under this applicant name. See the company

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  • P810020/S004Palacos E-Flow (Osteopal) Bone CementSmith & Nephew Richards, Inc. · 1998
  • K965224Empower Anterior Direct ScrewsSmith & Nephew Richards, Inc. · 1997
  • K963509Global Taper Tapered Hip System, GT SpectronSmith & Nephew Richards, Inc. · 1997
  • K960444Finn Rod to Rod ConnectorSmith & Nephew Richards, Inc. · 1997

Recent decisions in EWA

The EWA category page

  • K780474Audiometer Calibrator Model RA 310Tracor Instruments, Inc. · 1978

https://510kreport.com/device/K934432 · printed Nov 4, 2026

Cite this page

510(k) Report. “K934432: Otoview Endoscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934432

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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