510(k) · Cleared
ClearedClearfield Anti-Fog Sterile Wipe, Product Number 300-004
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tucson Medical Corp. · OCT Anti Fog Solution And Accessories, Endoscopy
Cleared on Dec 18, 1997 as substantially equivalent to K904871 (North American Marketing Corp., 1991) after a 23-day review. Its family tree reaches back 1 generation to 1991. 25 later devices descend from it.
- Decided
- Dec 18, 1997
- Review
- 23 days
- Class
- Class II
- Product code
- OCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904871 (1991). 25 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK904871 Medi-KleerNorth American Marketing Corp. · 1991
- This deviceK974454 Clearfield Anti-Fog Sterile Wipe, Product Number 300-004Tucson Medical Corp. · 1997
- 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 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · 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 | K904871 | Medi-Kleer | North American Marketing Corp. | 1991 | — |
| 0 (this device) | K974454 | Clearfield Anti-Fog Sterile Wipe, Product Number 300-004 | Tucson Medical Corp. | 1997 | — |
| +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 |
| 2012 | 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 |
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 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 K251068 KnoxFog Anti-fogging Devicescore 10.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K904871 | Medi-KleerSummary page 1…ernal Lens Anti-Fog Solution. Classification name: Endoscope Accessory (per 21 CFR section 876.1500). Predicate Device: ClearField Anti-Fog Sterile Wipe, 510(k) Number K904871/B. Device Description: Sterile cloth pre-saturated with Scc of Anti-Fog solution. Single Use. Intended Use: Intended for use a… | 1991 |
What descends from it? (25)
See all 252 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K062779 (New Wave Surgical Corporation, 2006) has gone furthest, with 23 descendants of its own.
How does its category compare?
All OCT devicesOCT 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
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCT
13in 2025
MAUDE reports naming product code OCT, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 0 | 27 |
| 2017 | 1 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 20 |
| 2019 | 1 | — | 0 | 20 |
| 2020 | 1 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 16 |
| 2022 | 1 | — | 1 | 10 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ClearField Anti-Fog Sterile Wipe is intended for use as an agent to keep external viewing surfaces clear of water vapor and condensation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974454 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974454: Clearfield Anti-Fog Sterile Wipe, Product Number 300-004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974454
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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