510(k) · Cleared
ClearedClearCam System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearcam, LLC · GCJ Laparoscope, General & Plastic Surgery
Cleared on Feb 19, 2020 as substantially equivalent to K170103 (Medeon Biodesign, Inc., 2017) after a 20-day review. Its family tree reaches back 7 generations to 1991. 3 later devices descend from it.
- Decided
- Feb 19, 2020
- Review
- 20 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K904871 (1991). 22 ancestors in all, the oldest K902683 (1990). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK904871 Medi-KleerNorth American Marketing Corp. · 1991
- 6 generations backK974454 Clearfield Anti-Fog Sterile Wipe, Product Number 300-004Tucson Medical Corp. · 1997
- 5 generations backK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006 · Recalled
- 4 generations backK080613 Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008
- 3 generations backK151117 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015
- 2 generations backK160172 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016
- 1 generation backK170103 Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017
- This deviceK200228 ClearCam SystemClearcam, LLC · 2020
- Descendant · cites it directly · 2 of its ownK241796 TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK253994 TroKit Laparoscope Lens WiperTroCare, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK260089 TL-10 Laparoscopic Scope CleanerScopix, Ltd. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904871 | Medi-Kleer | North American Marketing Corp. | 1991 | — |
| −6 | K974454 | Clearfield Anti-Fog Sterile Wipe, Product Number 300-004 | Tucson Medical Corp. | 1997 | — |
| −5 | K062779 | Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens… | New Wave Surgical Corporation | 2006 | 2 |
| −4 | 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 | — |
| −2 | K160172 | Laparoscope Lens Shield Device | Medeon Biodesign, Inc. | 2016 | — |
| −1 | K170103 | Laparoscope Lens Shield Device (LENS) | Medeon Biodesign, Inc. | 2017 | — |
| 0 (this device) | K200228 | ClearCam System | Clearcam, LLC | 2020 | — |
| +1 | K241796 | TroCare TroKit Laparoscope Lens Wiper (CP000626) | TroCare, LLC | 2024 | — |
| +2 | K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | 2026 | — |
| +2 | K260089 | TL-10 Laparoscopic Scope Cleaner | Scopix, Ltd. | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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 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
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 |
|---|---|---|---|
| * | K170103 | Laparoscope Lens Shield Device (LENS)Summary page 4…Classification: General & Plastic Surgery Predicate Device(s): Primary Predicate: ClickClean (K170103) Reference Device(s): EndoClear (K100346)… | 2017 |
| † | K100346 | Endoclear System | 2010 |
| † | K062779 | Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241796 | TroCare TroKit Laparoscope Lens Wiper (CP000626) | 2024 | 2 |
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 29 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 6 of the 22 ancestors have a recall of any class.
- Of its descendants, K241796 (TroCare, LLC, 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K170103.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 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?
The ClearCam System is indicated to provide lens clearing during laparoscopic procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200228 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200228: ClearCam System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200228
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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