510(k) · Cleared
ClearedInvisio Irl Digital Rigid Laparoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acmi Corporation · GCJ Laparoscope, General & Plastic Surgery
Cleared on Nov 1, 2004 as substantially equivalent to K013165 (Circon Acmi, 2002) and 2 other predicates after a 91-day review. Its family tree reaches back 5 generations to 1993. 1 of the 24 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 1, 2004
- Review
- 91 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K931154 (1993). 23 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet. 1 of the 24 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 4 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 3 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 2 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 1 generation backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- This deviceK042069 Invisio Irl Digital Rigid Laparoscope SystemAcmi Corporation · 2004
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope3 generations back · 1991
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −4 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −3 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −2 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −1 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| 0 (this device) | K042069 | Invisio Irl Digital Rigid Laparoscope System | Acmi Corporation | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 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.
1 device in this family has a Class I recall. 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013165 | Usa Series LaparoscopesSummary page 1…Classification Name: Laparoscope Surgical Camera and accessories 2. Predicate Devices: Circon's USA Series Laparoscope with various Tradenames (K013165) ACMI Electronic Video Cystonephroscope (ECN) System (K030960) Olympus Deflectable Tip Video Laparoscope (K955404… | 2002 |
| * | K030960 | Ecn Electronic Video CystonephroscopeSummary page 1…ssories 2. Predicate Devices: Circon's USA Series Laparoscope with various Tradenames (K013165) ACMI Electronic Video Cystonephroscope (ECN) System (K030960) Olympus Deflectable Tip Video Laparoscope (K955404) 3. Device Description: The lnvisio IRL Digital Rigid La… | 2003 |
| * | K955404 | Otv-S5 Oes Video SystemSummary page 1…es Laparoscope with various Tradenames (K013165) ACMI Electronic Video Cystonephroscope (ECN) System (K030960) Olympus Deflectable Tip Video Laparoscope (K955404) 3. Device Description: The lnvisio IRL Digital Rigid Laparoscope is a standard USA Series Laparoscope that i… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 3 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 23 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K013165.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Invisio IRL Digital Rigid Laparoscope System is intended for use, by qualified physicians, to provide access to, illumination, and visualization of body cavities, during endoscopic laparoscopic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042069 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042069: Invisio Irl Digital Rigid Laparoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042069
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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