510(k) · Cleared

Cleared

Isc-1000 Pentax Confocal Laser System

K042740510(k) TraditionalCleared Oct 19, 200415-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 Medical Company · GCJ Laparoscope, General & Plastic Surgery

Cleared on Oct 19, 2004 as substantially equivalent to K912581 (Carl Zeiss, Inc., 1991) after a 15-day review. Its family tree reaches back 1 generation to 1991. 16 later devices descend from it.

Decided: Oct 19, 2004
Review: 15 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K912581 (1991). 16 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK912581 Zeiss Confocal Laser Scanning Ophthalmoscope (Clso)Carl Zeiss, Inc. · 1991
This deviceK042740 Isc-1000 Pentax Confocal Laser SystemPentax Medical Company · 2004
Descendant · cites it directly · 13 of its ownK061666 Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and…Mauna Kea Technologies · 2006
Descendant · cites it directly · 13 of its ownK051585 F-400 SystemMauna Kea Technologies · 2005
Descendant · 2 generations on · 12 of its ownK111047 Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc. · 2011
Descendant · 3 generations on · 10 of its ownK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
Descendant · 3 generations on · 9 of its ownK141358 Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2005high 3 (2014) · low 0 (2007)2026

Most influential descendants

Showing 5 of 16 · See all

K061666Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and GastroflexMauna Kea Technologies · 2006 · cites it directly13descendants
K051585F-400 SystemMauna Kea Technologies · 2005 · cites it directly13descendants
K111047Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc. · 2011 · 2 generations on12descendants
K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · 3 generations on10descendants
K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014 · 3 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K912581	Zeiss Confocal Laser Scanning Ophthalmoscope (Clso)	Carl Zeiss, Inc.	1991	—
0 (this device)	K042740	Isc-1000 Pentax Confocal Laser System	Pentax Medical Company	2004	—
+1	K061666	Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and Gastroflex	Mauna Kea Technologies	2006	—
+1	K051585	F-400 System	Mauna Kea Technologies	2005	—
+2	K111047	Cellvizio 100 Series System with Confocal Miniprobes	Mauna Kea Technologies, Inc.	2011	—
+3	K132389	Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes…	Daniel & Daniel Consulting	2014	—
+3	K141358	Cellvizio 100 Series with System Confocal Miniprobes	Mauna Kea Technologies	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2010	1	0
2011	1	0
2014	3	0
2015	1	0
2016	1	0
2017	1	0
2019	1	0
2020	2	0
2021	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K042740, 1991–2025Source: 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 GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GCJ device

#1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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
*	K912581	Zeiss Confocal Laser Scanning Ophthalmoscope (Clso) Summary page 1 …Manufacturer PMN# Zeiss Confocal Laser Carl Zeiss, Inc. K912581 Device Description: The Pentax Confocal Laser System (software controlled device) is intended for use as a required accessory wi…	Carl Zeiss, Inc.	1991	—

Also cleared against K912581: 1 other device →

What descends from it? (16)

See all 16

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061666	Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and Gastroflex	Mauna Kea Technologies	2006	13
K051585	F-400 System	Mauna Kea Technologies	2005	13
K093624	Optiscan Model Optiscan Ceis	Optiscan Pty., Ltd.	2010	0

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?

Its one ancestor has no recall.
Of its descendants, K061666 (Mauna Kea Technologies, 2006) has gone furthest, with 13 descendants of its own.
1 other device also cites its predicate K912581.

How does its category compare?

All GCJ devices

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

FDA decisions per year · GCJ

21in 2025

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007high 6,047 (2024) · low 1,319 (2008)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	18	42	12	1,639
2008	19	73	16	1,319
2009	21	85	6	1,995
2010	24	122	30	2,657
2011	15	113	9	2,133
2012	17	88	1	1,526
2013	15	93	7 (1)	1,565
2014	19	90	2	1,714
2015	26	76	0	1,710
2016	27	99	5	2,080
2017	20	77	1	3,468
2018	21	88	1	2,562
2019	15	60	0	2,578
2020	28	61	0	2,618
2021	18	116	0	3,431
2022	20	103	1	3,945
2023	31	109	1	6,002
2024	29	90	0	6,047
2025	21	108	5	5,860
2026	26	122	1	—

What is it indicated for?

The Pentax confocal laser system is a required accessory for legally marketed video endoscopes equipped with a confocal laser imaging module. The system is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical track accessed by the endoscope. The system is applied when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042740 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042740: Isc-1000 Pentax Confocal Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042740

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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