510(k) · Cleared

Recalled · 2010

Stryker Scope Warmer

K053311510(k) TraditionalCleared Jan 27, 200660-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

Stryker Endoscopy · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jan 27, 2006 as substantially equivalent to K931895 (Applied Medical Resources, 1993) after a 60-day review. Its family tree reaches back 1 generation to 1993. 24 later devices descend from it. It has been recalled once.

Decided: Jan 27, 2006
Review: 60 days
Class: Class II
Product code: GCJ
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K931895 (1993). 24 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK931895 Endoscope AccessoryApplied Medical Resources · 1993
This deviceK053311 Stryker Scope WarmerStryker Endoscopy · 2006
Descendant · cites it directly · 23 of its ownK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006 · Recalled
Descendant · 2 generations on · 16 of its ownK080613 Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008
Descendant · 3 generations on · 8 of its ownK151117 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015
Descendant · 4 generations on · 7 of its ownK160172 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016
Descendant · 5 generations on · 6 of its ownK170103 Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2006high 3 (2022) · low 0 (2007)2026

Most influential descendants

Showing 5 of 24 · See all

K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…New Wave Surgical Corporation · 2006 · cites it directly23descendants
K080613Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008 · 2 generations on16descendants
K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015 · 3 generations on8descendants
K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016 · 4 generations on7descendants
K170103Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017 · 5 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K931895	Endoscope Accessory	Applied Medical Resources	1993	—
0 (this device)	K053311	Stryker Scope Warmer	Stryker Endoscopy	2006	—
+1	K062779	Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens…	New Wave Surgical Corporation	2006	2
+2	K080613	Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045	Minimally Invasive Devices, LLC	2008	—
+3	K151117	Laparoscope Lens Shield Device	Medeon Biodesign, Inc.	2015	—
+4	K160172	Laparoscope Lens Shield Device	Medeon Biodesign, Inc.	2016	—
+5	K170103	Laparoscope Lens Shield Device (LENS)	Medeon Biodesign, Inc.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2010	1	0
2015	2	0
2016	2	0
2017	2	0
2018	2	0
2019	1	0
2020	2	0
2022	3	0
2023	1	0
2024	2	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K053311, 1993–2026Source: 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
*	K931895	Endoscope Accessory Summary page 1 …1990. The Stryker Scope Warmer is substantially equivalent in terms of safety and effectiveness to currently marketed devices, including Applied Medical's Scope Warmer (K931895). The Stryker Scope Warmer is a new product developed by Stryker. The Stryker Scope Warmer is an endoscopic accessory, composed…	Applied Medical Resources	1993	—

Also cleared against K931895: 1 other device →

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K062779	Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…	New Wave Surgical Corporation	2006	23

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 21, 2010	Not classified	Z-2622-2010	Process control	Outer packaging seals have inconsistencies that have resulted in compromised seals and may result in compromised sterility.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K062779 (New Wave Surgical Corporation, 2006) has gone furthest, with 23 descendants of its own.
1 other device also cites its predicate K931895.

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 Stryker Scope Warmer is indicated for use with endoscopes. As such, this product is indicated for use prior to and during surgeries in which an endoscope is indicated. The Stryker Scope Warmer is intended to be used, prior to and during these procedures, to heat endoscopes so as to minimize fogging of the scope.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053311 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053311: Stryker Scope Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053311

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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