510(k) · Cleared
ClearedMedi-Kleer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North American Marketing Corp. · OCT Anti Fog Solution And Accessories, Endoscopy
Cleared on Sep 17, 1991 after a 323-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 26 later devices descend from it.
- Decided
- Sep 17, 1991
- Review
- 323 days
- Class
- Class II
- Product code
- OCT
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 1 citing it directly.
- This deviceK904871 Medi-KleerNorth American Marketing Corp. · 1991
- Descendant · cites it directly · 25 of its ownK974454 Clearfield Anti-Fog Sterile Wipe, Product Number 300-004Tucson Medical Corp. · 1997
- Descendant · 2 generations on · 23 of its ownK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006 · Recalled
- Descendant · 3 generations on · 16 of its ownK080613 Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008
- Descendant · 4 generations on · 8 of its ownK151117 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015
- Descendant · 5 generations on · 7 of its ownK160172 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K974454Clearfield Anti-Fog Sterile Wipe, Product Number 300-004Tucson Medical Corp. · 1997 · cites it directly25descendants
- K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…New Wave Surgical Corporation · 2006 · 2 generations on23descendants
- K080613Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008 · 3 generations on16descendants
- K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015 · 4 generations on8descendants
- K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904871 | Medi-Kleer | North American Marketing Corp. | 1991 | — |
| +1 | K974454 | Clearfield Anti-Fog Sterile Wipe, Product Number 300-004 | Tucson Medical Corp. | 1997 | — |
| +2 | K062779 | Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens… | New Wave Surgical Corporation | 2006 | 2 |
| +3 | K080613 | Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045 | Minimally Invasive Devices, LLC | 2008 | — |
| +4 | K151117 | Laparoscope Lens Shield Device | Medeon Biodesign, Inc. | 2015 | — |
| +5 | K160172 | Laparoscope Lens Shield Device | Medeon Biodesign, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974454 | Clearfield Anti-Fog Sterile Wipe, Product Number 300-004 | 1997 | 25 |
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, K974454 (Tucson Medical Corp., 1997) has gone furthest, with 25 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 | — |
https://510kreport.com/device/K904871 · printed Nov 6, 2026
Cite this page
510(k) Report. “K904871: Medi-Kleer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904871
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026