510(k) · Cleared
ClearedDefogging and Cleaning Solution- Flo-X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minimally Invasive Devices, LLC · OCT Anti Fog Solution And Accessories, Endoscopy
Cleared on Dec 23, 2010 as substantially equivalent to K982465 (Deroyal Industries, Inc., 1998) and 1 other predicate after a 118-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Dec 23, 2010
- Review
- 118 days
- Class
- Class II
- Product code
- OCT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K904871 (1991). 19 ancestors in all, the oldest K902683 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK904871 Medi-KleerNorth American Marketing Corp. · 1991
- 3 generations backK974454 Clearfield Anti-Fog Sterile Wipe, Product Number 300-004Tucson Medical Corp. · 1997
- 2 generations backK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006 · Recalled
- 1 generation backK080613 Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008
- This deviceK102452 Defogging and Cleaning Solution- Flo-XMinimally Invasive Devices, LLC · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904871 | Medi-Kleer | North American Marketing Corp. | 1991 | — |
| −3 | 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 |
| −1 | K080613 | Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045 | Minimally Invasive Devices, LLC | 2008 | — |
| 0 (this device) | K102452 | Defogging and Cleaning Solution- Flo-X | Minimally Invasive Devices, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K054249 | Covidien Auto-Suture Anti-Fog Solution (Dexide FRED) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K982465 | Deroyal Industries, Inc. DefoggerSummary page 4…21 CFR Part 876.1500, Endoscope and/or Accessories. Panel: General and Plastic Surgery Predicate Devices: KS44249 Covidien Auto-Suture Anti-Fog Solution (Dexide FRED) K982465 DeRoyal Industries, Inc. DeFogger K080613 Minimally Invasive Devices, Inc. FioShield™ System intended Use: The Defogging and C… | 1998 |
| * | K080613 | Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Summary page 4…ssories. Panel: General and Plastic Surgery Predicate Devices: KS44249 Covidien Auto-Suture Anti-Fog Solution (Dexide FRED) K982465 DeRoyal Industries, Inc. DeFogger K080613 Minimally Invasive Devices, Inc. FioShield™ System intended Use: The Defogging and Cleaning Solution is a single-use laparoscop… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 6 of the 19 ancestors have a recall of any class.
- 1 other device also cites its predicate K982465.
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. 2010, this device’s year, is highlighted.
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?
The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the laparoscope lens thereby maintaining visualization of the surgical site.
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/K102452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102452: Defogging and Cleaning Solution- Flo-X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102452
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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