510(k) · Cleared
ClearedOpClear System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cipher Surgical, Ltd. · OCX Endoscopic Irrigation/Suction System
Cleared on Feb 26, 2018 as substantially equivalent to K080613 (Minimally Invasive Devices, LLC, 2008) after a 269-day review. Its family tree reaches back 4 generations to 1991. 3 later devices descend from it.
- Decided
- Feb 26, 2018
- Review
- 269 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K904871 (1991). 19 ancestors in all, the oldest K902683 (1990). 3 later devices descend from it, 2 citing it directly.
- 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 deviceK171637 OpClear SystemCipher Surgical, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK222695 troCarWash™ SystemBiotex, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK233442 troCarWash™ SystemBiotex, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK221824 OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch…Cipher Surgical Limited · 2022
Most influential descendants
Showing 3 of 3 · See all- K222695troCarWash™ SystemBiotex, Inc. · 2023 · cites it directly1descendant
- K233442troCarWash™ SystemBiotex, Inc. · 2024 · 2 generations on0descendants
- K221824OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear…Cipher Surgical Limited · 2022 · cites it directly0descendants
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) | K171637 | OpClear System | Cipher Surgical, Ltd. | 2018 | — |
| +1 | K222695 | troCarWash™ System | Biotex, Inc. | 2023 | — |
| +2 | K233442 | troCarWash™ System | Biotex, Inc. | 2024 | — |
| +1 | K221824 | OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33)… | Cipher Surgical Limited | 2022 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 OCX? 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 OCX device
- #1 K251986 Auxiliary Water Tube Maj-855score 12.8 · 10 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 |
|---|---|---|---|
| * | K080613 | Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Summary page 4…h its 510(k) number is provided below: Device Name Manufacturer 510(k) Number Clear-Vu System Minimally Invasive K080613 Devices LLC Traditional 510(k)- OpClear Cipher Surgical Ltd.… | 2008 |
| † | K153513 | Insufflator 50L FM134 | 2016 |
| † | K962863 | Karl Storz Model 264305-20 Electronic Endoflator | 1996 |
What descends from it? (3)
2 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?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 8.8 years on median.
- 6 of the 19 ancestors have a recall of any class.
- Of its descendants, K222695 (Biotex, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K080613.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OCX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCX
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCX
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCX
33in 2025
MAUDE reports naming product code OCX, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 51 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 4 | 256 | 0 | 1 |
| 2013 | 3 | 106 | 0 | 1 |
| 2014 | 6 | 77 | 0 | 5 |
| 2015 | 2 | — | 1 | 9 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 5 | 60 | 0 | 18 |
| 2019 | 8 | 133 | 0 | 41 |
| 2020 | 4 | 88 | 11 | 11 |
| 2021 | 3 | 233 | 0 | 8 |
| 2022 | 6 | 84 | 2 | 18 |
| 2023 | 7 | 109 | 0 | 46 |
| 2024 | 4 | 74 | 0 | 21 |
| 2025 | 4 | 178 | 0 | 33 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The OpClear® System consists of a reusable control unit and a range of disposable sterile single-use accessories intended to remove visual obstructions such as condensation, blood and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintaining a clear image of the surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171637: OpClear System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171637
Report an extraction error
Are you the manufacturer?
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