510(k) Report

510(k) · Cleared

Cleared

Weco Endoscopic System with Fiber Optic Light

K951519510(k) TraditionalCleared Jun 14, 199572-day reviewClass I21 CFR 878.4160

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

Wells Johnson Co. · FWL Camera, Cine, Endoscopic, Without Audio

Cleared on Jun 14, 1995 after a 72-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Jun 14, 1995
Review
72 days
Class
Class I
Product code
FWL
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951519 Weco Endoscopic System with Fiber Optic LightWells Johnson Co. · 1995
  2. Descendant · cites it directly · 0 of its ownK972927 Endoscopes W/Permanent and Removable Eyepiece, Panoview Plus…Richard Wolf Medical Instruments Corp. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K972927Endoscopes W/Permanent and Removable Eyepiece, Panoview Plus Telescope W/Plug-on ConnectorRichard Wolf Medical Instruments Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951519Weco Endoscopic System with Fiber Optic LightWells Johnson Co.1995—
+1K972927Endoscopes W/Permanent and Removable Eyepiece, Panoview Plus Telescope…Richard Wolf Medical Instruments Corp.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K951519, 1995–1997Source: 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 FWL? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K972927Endoscopes W/Permanent and Removable Eyepiece, Panoview Plus Telescope W/Plug-on ConnectorRichard Wolf Medical Instruments Corp.19970

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, K972927 (Richard Wolf Medical Instruments Corp., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FWL devices

FWL Camera, Cine, Endoscopic, Without Audio: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FWL

FDA has decided no FWL device since 2007.

Median 510(k) review, days · FWL

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

Recalls per year · FWL

No recall names FWL since 2007.

Adverse event reports per year · FWL

2in 2018

2016: 12018: 2
2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code FWL, 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—00
20150—00
20160—01
20170—00
20180—02
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Wells Johnson Co.

15 FDA decisions under this applicant name. See the company

  • K991437Wells Johnson Infusion System, Model 20-6000-00Wells Johnson Co. · 1999
  • K984448Bircoll Balloon DissectorWells Johnson Co. · 1999
  • K971580Uas Ultrasonic Aspirator SystemWells Johnson Co. · 1997
  • K945876Weco Endoscopic System with Fiber Optic LightWells Johnson Co. · 1995
  • K945500Wells Johnson Fixation SystemWells Johnson Co. · 1995

Recent decisions in FWL

The FWL category page

  • K883760Storz Model 62 Ent Camera SystemStorz Instrument Co. · 1988

https://510kreport.com/device/K951519 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951519: Weco Endoscopic System with Fiber Optic Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951519

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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