510(k) Report

510(k) · Cleared

Cleared

Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic Procedures

K072814510(k) TraditionalCleared Apr 16, 2008198-day reviewClass I21 CFR 878.4800

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

Covidien · KDD Kit, Surgical Instrument, Disposable

Cleared on Apr 16, 2008 as substantially equivalent to K883018 (United States Surgical, A Division of Tyco Healthc, 1988) and 6 other predicates after a 198-day review. Its family tree reaches back 3 generations to 1994. 59 later devices descend from it.

Decided
Apr 16, 2008
Review
198 days
Class
Class I
Product code
KDD
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K940232 (1994). 15 ancestors in all, the oldest K883018 (1988). 59 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1995: 4 other ancestors1993: 1 other ancestor1992: 2 other ancestors1988: 1 other ancestor1994: 2 other ancestors1991: 1 other ancestor2008: 1 descendant cleared2009: 2 descendants cleared2011: 4 descendants cleared2010: 1 descendant cleared2016: 3 descendants cleared2015: 2 descendants cleared2024: 7 descendants cleared2013: 2 descendants cleared2014: 5 descendants cleared2012: 2 descendants cleared2017: 3 descendants cleared2018: 3 descendants cleared2022: 2 descendants cleared2019: 2 descendants cleared2020: 3 descendants cleared2025: 8 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared2021: 3 descendants clearedK940232 · Innerdyne Step Trocar Expandable Port, S.T.E.P. · Innerdyne Medical, Inc. · 1994K961940 · Innerdyne Step Trocar Expandable Port, Onestep · Innerdyne, Inc. · 1996 · recalledK012539 · Verastep · United States Surgical, A Division of Tyco Healthc · 20011990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 9 descendants4 generations forward: 10 descendants5 generations forward: 5 descendants6 generations forward: 4 descendants7 generations forward: 6 descendants8 generations forward: 5 descendants9 generations forward: 4 descendants10 generations forward: 3 descendants11 generations forward: 3 descendants12 generations forward: 5 descendants K012539 · Verastep · United States Surgical, A Division of Tyco Healthc · 2001K961940 · Innerdyne Step Trocar Expandable Port, Onestep · Innerdyne, Inc. · 1996 · recalledK940232 · Innerdyne Step Trocar Expandable Port, S.T.E.P. · Innerdyne Medical, Inc. · 19940+5+10
  1. Root · 3 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
  2. 2 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
  3. 1 generation backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
  4. This deviceK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
  5. Descendant · cites it directly · 58 of its ownK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
  6. Descendant · 2 generations on · 46 of its ownK090902 Spider Single Port Surgical Device, Support Arm Accessory, Model…Transenterix, Inc. · 2009 · Recalled
  7. Descendant · 2 generations on · 43 of its ownK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled
  8. Descendant · 3 generations on · 42 of its ownK120215 Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc. · 2012 · Recalled
  9. Descendant · 3 generations on · 39 of its ownK122532 DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · Recalled

Showing 5 of 59 descendants. See all descendants

Descendants cleared per year

2008: 12009: 22010: 12011: 42012: 22013: 22014: 52015: 22016: 32017: 32018: 32019: 22020: 32021: 32022: 22023: 32024: 72025: 82026: 3
2008high 8 (2025) · low 1 (2008)2026

Most influential descendants

Showing 5 of 59 · See all
  • K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008 · cites it directly58descendants
  • K090902Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003Transenterix, Inc. · 2009 · 2 generations on46descendants
  • K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · 2 generations on43descendants
  • K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…Intuitive Surgical, Inc. · 2012 · 3 generations on42descendants
  • K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2013 · 3 generations on39descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K940232Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc.1994—
−2K961940Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc.19961
−1K012539VerastepUnited States Surgical, A Division of Tyco Healthc2001—
0 (this device)K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced…Covidien2008—
+1K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States2008—
+2K090902Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002…Transenterix, Inc.20091
+2K112208Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc.201112
+3K120215Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc.20123
+3K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc.20136

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199110
199220
199310
199420
199540
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200920
201010
201140
201220
201320
201450
201520
201630
201730
201830
201920
202030
202130
202220
202330
202470
202580
202630
FIG. 1 — Lineage of K072814, 1994–2026Source: 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), 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 KDD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K883018Auto Suture Disp. Endoscopic Surg. Clip Applier
Summary page 1
…Convenience Kit CLASSIFICATION NAME: Convenience Kit PREDICATE DEVICE(S): K883018: Endo Clip* 5mm Clip Applier K914753: Roticulator Endo Dissect* 5mm,…
United States Surgical, A Division of Tyco Healthc1988—
*K914753Auto Suture (R) Articulating Endoscopic Clamp
Summary page 1
…Convenience Kit PREDICATE DEVICE(S): K883018: Endo Clip* 5mm Clip Applier K914753: Roticulator Endo Dissect* 5mm, Endo Grasp* 5mm, & Endo Mini-Shears* 5mm…
United States Surgical, A Division of Tyco Healthc1992—
*K920599Hook Surgical Instrument
Summary page 1
…ulator Endo Dissect* 5mm, Endo Grasp* 5mm, & Endo Mini-Shears* 5mm K920599: AcuClip* Right Angle Clip Applier K922123: Endo Catch* Gold…
Origin Medsystems, Inc.1992—
*K922123Auto Suture Disposable Endoscopic Specimen Pouch
Summary page 1
…Endo Mini-Shears* 5mm K920599: AcuClip* Right Angle Clip Applier K922123: Endo Catch* Gold K951589: Roticulator Endo Sciz* 5mm…
United States Surgical, A Division of Tyco Healthc1993—
*K951589Manual Surgical Insrument
Summary page 1
…0599: AcuClip* Right Angle Clip Applier K922123: Endo Catch* Gold K951589: Roticulator Endo Sciz* 5mm Hook Scissors…
United States Surgical, A Division of Tyco Healthc1995—
*K981941Multaport Cannula Reducer and Accessories
Summary page 1
…K951589: Roticulator Endo Sciz* 5mm Hook Scissors K981941: Dexide* 5mm Threaded Trocar K012539: VersaStep* Plus 12mm Trocar…
Dexide, Inc.1998—
*K012539Verastep
Summary page 1
…Hook Scissors K981941: Dexide* 5mm Threaded Trocar K012539: VersaStep* Plus 12mm Trocar All predicate devices manufactured by…
United States Surgical, A Division of Tyco Healthc2001—

Also cleared against K883018: 3 other devices →

What descends from it? (59)

See all 59

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States200858

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 14 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
  • 1 of the 15 ancestors has a recall of any class.
  • Of its descendants, K082619 (Covidien Lp, Formerly Registered AS United States, 2008) has gone furthest, with 58 descendants of its own.
  • 3 other devices also cite its predicate K883018.

How does its category compare?

All KDD devices

KDD Kit, Surgical Instrument, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · KDD

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDD

Too few KDD 510(k)s in any year since 2007 to give a median.

Recalls per year · KDD

12so far in 2026, the most since 2007

2007: 22008: 52009: 72010: 42012: 12015: 32017: 22019: 12022: 12023: 12024: 52025: 12026 (partial year): 12, 1 Class I
2007high 12 (2026) · low 0 (2011)2026

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

Adverse event reports per year · KDD

33in 2025

2010: 32011: 82012: 52013: 442014: 252015: 542016: 332017: 122018: 172019: 222020: 442021: 632022: 122023: 432024: 582025: 33
2007high 63 (2021) · low 0 (2007)2025

MAUDE reports naming product code KDD, 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
20070—20
20081—50
20090—70
20100—43
20110—08
20120—15
20130—044
20140—025
20150—354
20160—033
20170—212
20180—017
20190—122
20200—044
20210—063
20220—112
20230—143
20240—558
20250—133
20260—12 (1)—

What is it indicated for?

For Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K072814: Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic Procedures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072814

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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