510(k) · Cleared
ClearedLiVac Retractor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Livac Pty, Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Oct 20, 2016 as substantially equivalent to K133345 (Retraction Limited, 2014) after a 50-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Oct 20, 2016
- Review
- 50 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914190 (1992). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK914190 Auto Suture (R) Endoscopic Fan RetractorUnited States Surgical, A Division of Tyco Healthc · 1992
- 1 generation backK133345 Reveel Endoscopic RetractorRetraction Limited · 2014
- This deviceK162445 LiVac Retractor SystemLivac Pty, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK243399 Boehringer Laboratories Liver RetractorBoehringer Laboratories, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K243399Boehringer Laboratories Liver RetractorBoehringer Laboratories, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914190 | Auto Suture (R) Endoscopic Fan Retractor | United States Surgical, A Division of Tyco Healthc | 1992 | — |
| −1 | K133345 | Reveel Endoscopic Retractor | Retraction Limited | 2014 | — |
| 0 (this device) | K162445 | LiVac Retractor System | Livac Pty, Ltd. | 2016 | — |
| +1 | K243399 | Boehringer Laboratories Liver Retractor | Boehringer Laboratories, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 |
|---|---|---|---|
| * | K133345 | Reveel Endoscopic RetractorSummary page 5…K162445 5. Legally Marketed Predicate Device Reveel Endoscopic Retractor (K133345): Retraction Limited 6. Device Description The LiVac Retractor System is a soft silicone ring connected to suction tubing a… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243399 | Boehringer Laboratories Liver Retractor | 2025 | 0 |
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 24 years and passes through 3 companies; a new generation was cleared every 21.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K243399 (Boehringer Laboratories, LLC, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 LiVac Retractor is designed as an organ and tissue retractor for use in laparoscopic procedures to elevate organs and tissue to provide improved access and visualisation of surgical sites.
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/K162445 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162445: LiVac Retractor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162445
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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