510(k) Report

510(k) · Cleared

Cleared

Endoscopic Anti Fog Device

K993604510(k) TraditionalCleared Mar 3, 2000130-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

Mectra Labs, Inc. · OCT Anti Fog Solution And Accessories, Endoscopy

Cleared on Mar 3, 2000 after a 130-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 24 later devices descend from it.

Decided
Mar 3, 2000
Review
130 days
Class
Class II
Product code
OCT
Recalls
None
Predicates
0

24 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2017: 2 descendants cleared2008: 1 descendant cleared2015: 2 descendants cleared2018: 2 descendants cleared2022: 3 descendants cleared2010: 1 descendant cleared2016: 2 descendants cleared2026: 3 descendants cleared2025: 1 descendant cleared2023: 1 descendant cleared2024: 2 descendants cleared2019: 1 descendant cleared2020: 2 descendants cleared200020052010201520202025
  1. This deviceK993604 Endoscopic Anti Fog DeviceMectra Labs, Inc. · 2000
  2. Descendant · cites it directly · 23 of its ownK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006 · Recalled
  3. 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
  4. Descendant · 3 generations on · 8 of its ownK151117 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015
  5. Descendant · 4 generations on · 7 of its ownK160172 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016
  6. 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

2006: 12008: 12010: 12015: 22016: 22017: 22018: 22019: 12020: 22022: 32023: 12024: 22025: 12026: 3
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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K993604Endoscopic Anti Fog DeviceMectra Labs, Inc.2000—
+1K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens…New Wave Surgical Corporation20062
+2K080613Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC2008—
+3K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc.2015—
+4K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc.2016—
+5K170103Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
201010
201520
201620
201720
201820
201910
202020
202230
202310
202420
202510
202630
FIG. 1 — Lineage of K993604, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OCT? 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 OCT device

  1. #1 K251068 KnoxFog Anti-fogging Devicescore 10.8 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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.

NumberDeviceApplicantDecidedDescendants
K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…New Wave Surgical Corporation200623

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?

  • Of its descendants, K062779 (New Wave Surgical Corporation, 2006) has gone furthest, with 23 descendants of its own.

How does its category compare?

All OCT devices

OCT Anti Fog Solution And Accessories, Endoscopy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCT

1in 2025

2007: 12008: 12010: 12011: 12012: 12016: 12017: 12019: 12020: 12022: 12024: 12025: 1
2007high 1 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCT

Too few OCT 510(k)s in any year since 2007 to give a median.

Recalls per year · OCT

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OCT

13in 2025

2015: 132016: 272017: 182018: 202019: 202020: 142021: 162022: 102023: 132024: 92025: 13
2007high 27 (2016) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
20090—00
20101—00
20111—00
20121—00
20130—00
20140—00
20150—013
20161—027
20171—018
20180—020
20191—020
20201—014
20210—016
20221—110
20230—013
20241—09
20251—013
20260—0—

What is it indicated for?

Endoscopic Anti Fog Device is indicated for use during Endoscopic, laparoscopic, gastroscopic, and arthroscopic procedures, as well as any other procedures which require the use of an endsoscope device, to prevent fogging of the endoscope lens.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Mectra Labs, Inc.

9 FDA decisions under this applicant name. See the company

  • K113080TubalgatorMectra Labs, Inc. · 2012
  • K033880Electro-LubeMectra Labs, Inc. · 2004
  • K021247Pneumoperitoneum Insufflation NeedleMectra Labs, Inc. · 2002
  • K955352Suction Cautery ProbeMectra Labs, Inc. · 1996
  • K934547Mectra TrocarMectra Labs, Inc. · 1994

Recent decisions in OCT

The OCT category page

  • K251068KnoxFog Anti-fogging DeviceUv One Hygienics, Inc. · 2025
  • K231822GOLFF Sterile Anti-Fog SolutionBatrik Medical Manufacturing, Inc. · 2024
  • K221293E-Brik Visualization AssistantJdi Surgical, Inc. · 2022
  • K190864Konix Anti-Fog SolutionTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler · 2020
  • K181887AMD Anti-Fog SolutionAdvanced Medical Design Co., Ltd. · 2019

https://510kreport.com/device/K993604 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993604: Endoscopic Anti Fog Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993604

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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