510(k) · Cleared

Recalled · Class II · 2016

Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp)

K062779510(k) TraditionalCleared Oct 5, 200617-day reviewClass II21 CFR 876.1500Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

New Wave Surgical Corporation · GCJ Laparoscope, General & Plastic Surgery

Cleared on Oct 5, 2006 as substantially equivalent to K993604 (Mectra Labs, Inc., 2000) and 9 other predicates after a 17-day review. Its family tree reaches back 2 generations to 1991. 23 later devices descend from it. It has been recalled 2 times.

Decided: Oct 5, 2006
Review: 17 days
Class: Class II
Product code: GCJ
Recalls: 2
Predicates: 10

Its longest line of descent runs back 2 generations to K904871 (1991). 15 ancestors in all. 23 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 2 generations backK904871 Medi-KleerNorth American Marketing Corp. · 1991
1 generation backK974454 Clearfield Anti-Fog Sterile Wipe, Product Number 300-004Tucson Medical Corp. · 1997
This deviceK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006
Descendant · cites it directly · 16 of its ownK080613 Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008
Descendant · 2 generations on · 8 of its ownK151117 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015
Descendant · 3 generations on · 7 of its ownK160172 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016
Descendant · 4 generations on · 6 of its ownK170103 Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017
Descendant · 5 generations on · 4 of its ownK192891 Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2019

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2008high 3 (2022) · low 0 (2009)2026

Most influential descendants

Showing 5 of 23 · See all

K080613Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008 · cites it directly16descendants
K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015 · 2 generations on8descendants
K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016 · 3 generations on7descendants
K170103Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017 · 4 generations on6descendants
K192891Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2019 · 5 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K904871	Medi-Kleer	North American Marketing Corp.	1991	—
−1	K974454	Clearfield Anti-Fog Sterile Wipe, Product Number 300-004	Tucson Medical Corp.	1997	—
0 (this device)	K062779	Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens…	New Wave Surgical Corporation	2006	—
+1	K080613	Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045	Minimally Invasive Devices, LLC	2008	—
+2	K151117	Laparoscope Lens Shield Device	Medeon Biodesign, Inc.	2015	—
+3	K160172	Laparoscope Lens Shield Device	Medeon Biodesign, Inc.	2016	—
+4	K170103	Laparoscope Lens Shield Device (LENS)	Medeon Biodesign, Inc.	2017	—
+5	K192891	Laparoscope Lens Shield Device (LENS)	Medeon Biodesign, Inc.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	2	0
1996	1	0
1998	1	0
1999	2	0
2000	1	0
2002	1	0
2004	1	0
2005	1	0
2006	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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 K062779, 1991–2026Source: 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? (10)

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
*	K993604	Endoscopic Anti Fog Device Summary page 1 …upplies and devices: Predicate devices using sterile antifog solutions in laparoscopic procedures: Endoscopic Anti Fog Device (Mister Clear) 510k Number K993604 Clear-It Anti-Fog Solution 510k Number K022826 ClearField Anti-Fog Sterile Wipe…	Mectra Labs, Inc.	2000	—
*	K022826	Clear-IT Anti-Fog, Model PS003 Summary page 1 …aroscopic procedures: Endoscopic Anti Fog Device (Mister Clear) 510k Number K993604 Clear-It Anti-Fog Solution 510k Number K022826 ClearField Anti-Fog Sterile Wipe 510k Number K974454 Predicate devices that defog the laparoscope by wa…	Preservation Solutions, Inc.	2002	—
*	K974454	Clearfield Anti-Fog Sterile Wipe, Product Number 300-004 Summary page 1 …510k Number K993604 Clear-It Anti-Fog Solution 510k Number K022826 ClearField Anti-Fog Sterile Wipe 510k Number K974454 Predicate devices that defog the laparoscope by warming the scope in a heated solution: Applied Medical's Scope Warmer…	Tucson Medical Corp.	1997	—
*	K931895	Endoscope Accessory Summary page 1 …umber K974454 Predicate devices that defog the laparoscope by warming the scope in a heated solution: Applied Medical's Scope Warmer 510k Number K931895 Stryker's Scope Warmer 510k Number K053311 Deroyal Industries, Inc Defogger…	Applied Medical Resources	1993	—
*	K053311	Stryker Scope Warmer Summary page 1 …scope in a heated solution: Applied Medical's Scope Warmer 510k Number K931895 Stryker's Scope Warmer 510k Number K053311 Deroyal Industries, Inc Defogger 510k Number K982465 OR Solution Scope Holder…	Stryker Endoscopy	2006	1
*	K982465	Deroyal Industries, Inc. Defogger Summary page 1 …510k Number K931895 Stryker's Scope Warmer 510k Number K053311 Deroyal Industries, Inc Defogger 510k Number K982465 OR Solution Scope Holder 510k Number K051979 Predicate devices that are disposable and use batteri…	Deroyal Industries, Inc.	1998	1
*	K051979	Ors Model 6000 Endoscope Holder Summary page 1 …510k Number K053311 Deroyal Industries, Inc Defogger 510k Number K982465 OR Solution Scope Holder 510k Number K051979 Predicate devices that are disposable and use batteries to power an electrical resistance heating mechanism: Surgical Medical De…	O.R. Solutions, Inc.	2005	—
*	K023506	Surgical Medical Device Cautery Summary page 1 …dicate devices that are disposable and use batteries to power an electrical resistance heating mechanism: Surgical Medical Device Cautery 510K Number K023506 Predicate devices that are battery operated and disposable: The following battery-operated device is used for laparoscopic surge…	Modern Medical Equipment Mfg., Ltd.	2004	—
*	K052797	Lapevac, Filtration Device for the Periotoneum Summary page 2 …device containing batteries that is disposed after every laparoscopic surgery. Buffalo Filter's LapEvac 51 Ok Number K052797 Circon Surgiflex Wave Suction-Irrigator System 51 Ok Number K992126 Comparison Table: Characteristic D.t.E.L.P…	Medtek Devices, Inc.	2006	—
*	K992126	Circon Surgiflex Wave Tsunami Suction-Irrigation System Summary page 2 …= Page 2 === Buffalo Filter's LapEvac 51 Ok Number K052797 Circon Surgiflex Wave Suction-Irrigator System 51 Ok Number K992126 Comparison Table: Characteristic D.t.E.L.P Clear-It Anti- Deroyal OR Stryker's and Material…	Circon Corp.	1999	—

What descends from it? (23)

See all 23

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

Number	Device	Applicant	Decided	Descendants
K080613	Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045	Minimally Invasive Devices, LLC	2008	16
K182080	Scope Antifogging System	Xodus Medical, Inc.	2018	1
K163257	VitreOx Anti-fog Solution	Sio2 Nanotech, LLC	2017	1
K150569	LaparoVue	Buffalo Filter, LLC	2015	1
K221533	Plasma Shield	Plasmatica, Ltd.	2022	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 4, 2016	Class II	Z-0889-2017	Employee error	Product sterility is compromised due to breach of the sterile barrier
Oct 4, 2016	Class II	Z-0890-2017	Employee error	Product sterility is compromised due to breach of the sterile barrier

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
4 of the 15 ancestors have a recall of any class.
Of its descendants, K080613 (Minimally Invasive Devices, LLC, 2008) has gone furthest, with 16 descendants of its own.

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?

DHELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

DELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062779 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062779: Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062779

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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