510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Adapt Laparoscopic Port & Adapt Reducer Cap

K010007510(k) TraditionalCleared Feb 22, 200151-day reviewClass II21 CFR 876.1500Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Taut, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Feb 22, 2001 after a 51-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 77 later devices descend from it. It has been recalled 3 times.

Decided
Feb 22, 2001
Review
51 days
Class
Class II
Product code
GCJ
Recalls
3
Predicates
0

77 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2007: 3 descendants cleared2008: 3 descendants cleared2010: 5 descendants cleared2012: 6 descendants cleared2018: 4 descendants cleared2015: 2 descendants cleared2024: 7 descendants cleared2009: 3 descendants cleared2011: 7 descendants cleared2016: 3 descendants cleared2022: 2 descendants cleared2013: 2 descendants cleared2014: 5 descendants cleared2017: 3 descendants cleared2019: 2 descendants cleared2020: 3 descendants cleared2025: 8 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared2021: 3 descendants cleared200020052010201520202025
  1. This deviceK010007 Adapt Laparoscopic Port & Adapt Reducer CapTaut, Inc. · 2001
  2. Descendant · cites it directly · 69 of its ownK070158 R-Port Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007
  3. Descendant · cites it directly · 68 of its ownK073170 R-Port II Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007
  4. Descendant · 2 generations on · 58 of its ownK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
  5. Descendant · 3 generations on · 46 of its ownK090902 Spider Single Port Surgical Device, Support Arm Accessory, Model…Transenterix, Inc. · 2009 · Recalled
  6. Descendant · 3 generations on · 43 of its ownK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled

Showing 5 of 77 descendants. See all descendants

Descendants cleared per year

2007: 32008: 32009: 32010: 52011: 72012: 62013: 22014: 52015: 22016: 32017: 32018: 42019: 22020: 32021: 32022: 22023: 32024: 72025: 82026: 3
2007high 8 (2025) · low 2 (2013)2026

Most influential descendants

Showing 5 of 77 · See all
  • K070158R-Port Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007 · cites it directly69descendants
  • K073170R-Port II Laparoscopic Access DeviceAdvanced Surgical Concepts · 2007 · cites it directly68descendants
  • K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008 · 2 generations on58descendants
  • K090902Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003Transenterix, Inc. · 2009 · 3 generations on46descendants
  • K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · 3 generations on43descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010007Adapt Laparoscopic Port & Adapt Reducer CapTaut, Inc.2001—
+1K070158R-Port Laparoscopic Access DeviceAdvanced Surgical Concepts2007—
+1K073170R-Port II Laparoscopic Access DeviceAdvanced Surgical Concepts2007—
+2K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States2008—
+3K090902Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002…Transenterix, Inc.20091
+3K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.201112

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200730
200830
200930
201050
201170
201260
201320
201450
201520
201630
201730
201840
201920
202030
202130
202220
202330
202470
202580
202630
FIG. 1 — Lineage of K010007, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (77)

See all 77

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070158R-Port Laparoscopic Access DeviceAdvanced Surgical Concepts200769
K073170R-Port II Laparoscopic Access DeviceAdvanced Surgical Concepts200768
K073719Asc Triport Laparoscopic Access DeviceAdvanced Surgical Concepts200813
K082156Adapt Universal Laparoscopic Port, Model 405940, 405912, 40591213Teleflex Medical20083
K070352Mini Lap Pediatric Instruments with Medusa Clamping SystemMini Lap Technologies, Inc.20071
K121796Weck Reusable ObturatorTeleflexmedical, Inc.20120
K121380Weck Vista Optical Bladeless Laparoscopic Access PortTeleflexmedical, Inc.20120
K101671Single Site Flexible Bladeless ObturatorTeleflexmedical, Inc.20100

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 11, 2014Class IIZ-1326-2014Nonconforming Material/ComponentComplaints of leakage of insufflation gas through the device.
Mar 11, 2014Class IIZ-1279-2014Nonconforming Material/ComponentComplaints 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, 2014Class IIZ-1284-2014Nonconforming Material/ComponentComplaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K070158 (Advanced Surgical Concepts, 2007) has gone furthest, with 69 descendants of its own.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

More from Taut, Inc.

16 FDA decisions under this applicant name. See the company

  • K023261Adapt Balloon Open Access Port, Model 41244Taut, Inc. · 2002
  • K021731Adapt Open Access Port, Model 41233Taut, Inc. · 20022 recalls
  • K011018Taut Balloon Catheter, Model 50640Taut, Inc. · 2001
  • K003703Taut-Insufflation NeedleTaut, Inc. · 2001
  • K992904Mini-PortTaut, Inc. · 1999

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https://510kreport.com/device/K010007 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010007: Adapt Laparoscopic Port & Adapt Reducer Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010007

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026