510(k) · Cleared

Cleared

HOPKINS Telescopes

K221004510(k) TraditionalCleared Dec 20, 2022259-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

Karl Storz Endoscopy America, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Dec 20, 2022 as substantially equivalent to K935279 (KARL STORZ Endoscopy-America, Inc., 1994) after a 259-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.

Decided: Dec 20, 2022
Review: 259 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K935279 (1994). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK935279 Karl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz…KARL STORZ Endoscopy-America, Inc. · 1994
This deviceK221004 HOPKINS TelescopesKarl Storz Endoscopy America, Inc. · 2022
Descendant · cites it directly · 2 of its ownK233333 KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG · 2023
Descendant · 2 generations on · 0 of its ownK254242 KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG · 2026
Descendant · 2 generations on · 0 of its ownK253972 IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG · 2026

Most influential descendants

Showing 3 of 3 · See all

K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG · 2023 · cites it directly2descendants
K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG · 2026 · 2 generations on0descendants
K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935279	Karl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz Hopkins II Rigid…	KARL STORZ Endoscopy-America, Inc.	1994	—
0 (this device)	K221004	HOPKINS Telescopes	Karl Storz Endoscopy America, Inc.	2022	—
+1	K233333	KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit	Karl Storz SE & CO. KG	2023	—
+2	K254242	KARL STORZ ICG Imaging System with RUBINA® Lens	Karl Storz SE & CO. KG	2026	—
+2	K253972	IMAGE1 (TC400US); X-to-4U Adapter (TC040)	Karl Storz SE & CO. KG	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0
2026	2	0

FIG. 1 — Lineage of K221004, 1994–2026Source: 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

Get a 510(k) Report

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
*	K935279	Karl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz Hopkins II Rigid… Summary page 4 …tory Class: II Product Code: GCJ Classification General and Plastic Surgery Panel: Predicate KARL STORZ HOPKINS I and II Rigid Autoclavable Telescopes (K935279) Device(s): Device The HOPKINS Telescopes are rigid telescopes that utilize the rod lens Description: technolog…	KARL STORZ Endoscopy-America, Inc.	1994	—

Also cleared against K935279: 4 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K233333	KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit	Karl Storz SE & CO. KG	2023	2

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, K233333 (Karl Storz SE & CO. KG, 2023) has gone furthest, with 2 descendants of its own.
4 other devices also cite its predicate K935279.

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. 2022, this device’s year, is highlighted.

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 HOPKINS Telescopes are intended to provide visualization during laparoscopy, thoracoscopy and general surgery in adults and pediatrics.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K221004 · printed Nov 4, 2026

Cite this page

510(k) Report. “K221004: HOPKINS Telescopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221004

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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