510(k) · Cleared
Recalled · Class II · 2014Adapt Universal Laparoscopic Port, Model 405940, 405912, 40591213
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 10, 2008 as substantially equivalent to K010007 (Taut, Inc., 2001) after a 42-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 10, 2008
- Review
- 42 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010007 (2001). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK010007 Adapt Laparoscopic Port & Adapt Reducer CapTaut, Inc. · 2001 · Recalled
- This deviceK082156 Adapt Universal Laparoscopic Port, Model 405940, 405912, 40591213Teleflex Medical · 2008
- Descendant · cites it directly · 0 of its ownK121796 Weck Reusable ObturatorTeleflexmedical, Inc. · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK121380 Weck Vista Optical Bladeless Laparoscopic Access PortTeleflexmedical, Inc. · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK112456 Adapt (TM) Universal Balloon Open Access PortTeleflexmedical, Inc. · 2011 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K121796Weck Reusable ObturatorTeleflexmedical, Inc. · 2012 · cites it directly0descendants
- K121380Weck Vista Optical Bladeless Laparoscopic Access PortTeleflexmedical, Inc. · 2012 · cites it directly0descendants
- K112456Adapt (TM) Universal Balloon Open Access PortTeleflexmedical, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010007 | Adapt Laparoscopic Port & Adapt Reducer Cap | Taut, Inc. | 2001 | 3 |
| 0 (this device) | K082156 | Adapt Universal Laparoscopic Port, Model 405940, 405912, 40591213 | Teleflex Medical | 2008 | — |
| +1 | K121796 | Weck Reusable Obturator | Teleflexmedical, Inc. | 2012 | 3 |
| +1 | K121380 | Weck Vista Optical Bladeless Laparoscopic Access Port | Teleflexmedical, Inc. | 2012 | 3 |
| +1 | K112456 | Adapt (TM) Universal Balloon Open Access Port | Teleflexmedical, Inc. | 2011 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K010007 | Adapt Laparoscopic Port & Adapt Reducer CapSummary page 2…oposed ADAPtTM Universal Laparoscopic Port is substantially equivalent to the predicate device: The ADAPt TM Laparoscopic Teleflex Medical, Inc. / K010007 02/22/2001 Port and Accessory Taut, Inc. I. Comparison To Predicate Device The basic design and f… | 2001 |
What descends from it? (3)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2014 | Class II | Z-1280-2014 | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. |
| Mar 11, 2014 | Class II | Z-1281-2014 | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. |
| Mar 11, 2014 | Class II | Z-1276-2014 | Nonconforming Material/Component | Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures. |
| Mar 11, 2014 | Class II | Z-1323-2014 | Nonconforming Material/Component | Complaints of leakage of insufflation gas through the device. |
| May 12, 2010 | Not classified | Z-1890-2010 | Other | Balloon does not hold air or water once inflated. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 ADAPt™ Universal Laparoscopic Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic. surgical devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082156: Adapt Universal Laparoscopic Port, Model 405940, 405912, 40591213.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082156
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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