510(k) · Cleared

Cleared

Sightfix

K024251510(k) TraditionalCleared Mar 18, 200385-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

World of Medicine Lemke GmbH · GCJ Laparoscope, General & Plastic Surgery

Cleared on Mar 18, 2003 as substantially equivalent to K982013 (Mgb Endoskopische Gerate GmbH, 1998) and 2 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1994.

Decided: Mar 18, 2003
Review: 85 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K935279 (1994). 4 ancestors in all, the oldest K893121 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK935279 Karl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz…KARL STORZ Endoscopy-America, Inc. · 1994
1 generation backK982013 MGB Lapalux TelescopeMgb Endoskopische Gerate GmbH · 1998
This deviceK024251 SightfixWorld of Medicine Lemke GmbH · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K935279	Karl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz Hopkins II Rigid…	KARL STORZ Endoscopy-America, Inc.	1994	—
−1	K982013	MGB Lapalux Telescope	Mgb Endoskopische Gerate GmbH	1998	—
0 (this device)	K024251	Sightfix	World of Medicine Lemke GmbH	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1999	1	0

FIG. 1 — Lineage of K024251, 1994–2003Source: 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? (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
*	K982013	MGB Lapalux Telescope Summary page 1 …Class 11. The device is described in 21 C.F.R. 8 876.1500. The product COLC for t device is GCJ. IV. Predicate Device: 0 MGB LAPALUX Telescope (K9820 13) manufactured by MGB Endoskopische Gerate GmbH 0 Robotrac TM Retractor Arm (Unitrac) (K893 121) manufactur…	Mgb Endoskopische Gerate GmbH	1998	—
*	K893121	Robotrac (TM) Retractor Arm Summary page 1 …edicate Device: 0 MGB LAPALUX Telescope (K9820 13) manufactured by MGB Endoskopische Gerate GmbH 0 Robotrac TM Retractor Arm (Unitrac) (K893 121) manufactured by Aesculap Instruments Corp. 0 KSEA Endoscope Holder (K990334) manufactured by Karl Storz E…	Aesculap Instruments Corp.	1989	—
*	K990334	Ksea Endoscope Holder Summary page 1 …Gerate GmbH 0 Robotrac TM Retractor Arm (Unitrac) (K893 121) manufactured by Aesculap Instruments Corp. 0 KSEA Endoscope Holder (K990334) manufactured by Karl Storz Endoscopy- America, Inc. V. Intended Use: The SightFix is intended to allow…	KARL STORZ Endoscopy-America, Inc.	1999	—

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.

What does this lineage say?

The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
None of the 4 ancestors has a recall.

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 SightFix is intended to allow access and observation of body cavities and the surgical field during diagnostic and therapeutic procedures in laparoscopy and open surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024251 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024251: Sightfix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024251

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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