510(k) Report

510(k) · Cleared

Cleared

FE-34TH, Fiber Esophagoscope

K951198510(k) TraditionalCleared May 30, 199575-day reviewClass II21 CFR 876.1500

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

Pentax Precision Instrument Corp. · GCL Esophagoscope, General & Plastic Surgery

Cleared on May 30, 1995 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 30, 1995
Review
75 days
Class
Class II
Product code
GCL
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K951198Source: FDA 510(k) database · 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.

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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?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All GCL devices

GCL Esophagoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCL

FDA has decided no GCL device since 2007.

Median 510(k) review, days · GCL

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

Recalls per year · GCL

No recall names GCL since 2007.

Adverse event reports per year · GCL

1in 2025

2015: 32016: 42020: 22021: 92022: 32023: 22024: 22025: 1
2007high 9 (2021) · low 0 (2007)2025

MAUDE reports naming product code GCL, 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—03
20160—04
20170—00
20180—00
20190—00
20200—02
20210—09
20220—03
20230—02
20240—02
20250—01
20260—0—

More from Pentax Precision Instrument Corp.

67 FDA decisions under this applicant name. See the company

  • K041395EG-3630URPentax Precision Instrument Corp. · 2004
  • K041397EG-3830UTPentax Precision Instrument Corp. · 20041 recall
  • K041396FG-36UX Fiber Ultrasound GastroscopePentax Precision Instrument Corp. · 20041 recall
  • K031789EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp. · 2003
  • K023401EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp. · 2003

Recent decisions in GCL

The GCL category page

  • K951197FE-24X, Fiber EsophagoscopePentax Precision Instrument Corp. · 1995
  • K9345105,6,7,9,10,11,12MM Blunt-Tip Trocar Obtur/ThreadPhx Technologies Corp. · 1994
  • K922086Bard Biopsy ForcepsC.R. Bard, Inc. · 1992

https://510kreport.com/device/K951198 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951198: FE-34TH, Fiber Esophagoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951198

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