510(k) · Cleared

Recalled · Class II · 2016

ES-3800, Video Sigmoidoscope

K951577510(k) TraditionalCleared Mar 21, 1996352-day reviewClass II21 CFR 876.1500Recalls 1

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. · FAM Sigmoidoscope And Accessories, Flexible/Rigid

Cleared on Mar 21, 1996 as substantially equivalent to K792341 (Pentax Precision Instrument Corp., 1979) and 2 other predicates after a 352-day review. Its family tree reaches back 1 generation to 1979. 1 later device descends from it. It has been recalled once.

Decided: Mar 21, 1996
Review: 352 days
Class: Class II
Product code: FAM
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K792341 (1979). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK792341 Pentax Flexible Sigmoidoscope Mod. FS-34Pentax Precision Instrument Corp. · 1979
This deviceK951577 ES-3800, Video SigmoidoscopePentax Precision Instrument Corp. · 1996
Descendant · cites it directly · 0 of its ownK964131 EndoscopeAkos Biomedical, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all

K964131EndoscopeAkos Biomedical, Inc. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K792341	Pentax Flexible Sigmoidoscope Mod. FS-34	Pentax Precision Instrument Corp.	1979	—
0 (this device)	K951577	ES-3800, Video Sigmoidoscope	Pentax Precision Instrument Corp.	1996	—
+1	K964131	Endoscope	Akos Biomedical, Inc.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K951577, 1979–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FAM? 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K792341	Pentax Flexible Sigmoidoscope Mod. FS-34 Summary page 1 …: ES-3800, Video Sigmoidoscope Classification Name: Sigmoidoscope, flexible (78FAM), 876.1500 3. PREDICATED DEVICE(S) INFORMATION: 1. FS-34, Fiber Sigmoidoscope Pentax K792341 2. VB-1530/ 1830, Video Bronchoscope Pentax K934920 3. EPM-3300, Video Processor Pentax - K934918 4. DEVICE DESCRIPTION: The ES…	Pentax Precision Instrument Corp.	1979	—
*	K934920	VB-1830/VB-1530, Video Bronchoscope Summary page 1 …Sigmoidoscope, flexible (78FAM), 876.1500 3. PREDICATED DEVICE(S) INFORMATION: 1. FS-34, Fiber Sigmoidoscope Pentax K792341 2. VB-1530/ 1830, Video Bronchoscope Pentax K934920 3. EPM-3300, Video Processor Pentax - K934918 4. DEVICE DESCRIPTION: The ES-3800, Video Sigmoidoscope, must be used with a Vide…	Pentax Precision Instrument Corp.	1994	—
*	K934918	Epm-3300 Video Processor Summary page 1 …PREDICATED DEVICE(S) INFORMATION: 1. FS-34, Fiber Sigmoidoscope Pentax K792341 2. VB-1530/ 1830, Video Bronchoscope Pentax K934920 3. EPM-3300, Video Processor Pentax - K934918 4. DEVICE DESCRIPTION: The ES-3800, Video Sigmoidoscope, must be used with a Video Processor (a software controlled device). Th…	Pentax Precision Instrument Corp.	1994	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K964131	Endoscope	Akos Biomedical, Inc.	1997	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 6, 2016	Class II	Z-2075-2016	Device Design	Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K964131 (Akos Biomedical, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FAM devices

FAM Sigmoidoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FAM

FDA has decided no FAM device since 2007.

Median 510(k) review, days · FAM

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

Recalls per year · FAM

No recall names FAM since 2007.

Adverse event reports per year · FAM

3in 2025

2007high 11 (2024) · low 0 (2007)2025

MAUDE reports naming product code FAM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	2
2010	—	2
2011	—	0
2012	—	3
2013	—	0
2014	—	1
2015	—	0
2016	—	3
2017	—	0
2018	—	0
2019	—	2
2020	—	0
2021	—	0
2022	—	3
2023	—	4
2024	—	11
2025	—	3
2026	—	—

What is it indicated for?

The ES-3800, Video Sigmoidoscope, is intended to provide optical visualization of, and therapeutic access to, the Lower Gastrointestinal Tract (extent of exam, sigmoid colon). The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel.

The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K951577 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951577: ES-3800, Video Sigmoidoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951577

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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