510(k) Report

510(k) · Cleared

Cleared

Multaport Cannula Reducer and Accessories

K981941510(k) TraditionalCleared Jul 29, 199857-day reviewClass II21 CFR 876.1500

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

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

Cleared on Jul 29, 1998 as substantially equivalent to K912980 (Dexide, Inc., 1991) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 1991. 61 later devices descend from it.

Decided
Jul 29, 1998
Review
57 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K912980 (1991). 2 ancestors in all. 61 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor2008: 2 descendants cleared1999: 1 descendant cleared2009: 2 descendants cleared2011: 4 descendants cleared2010: 1 descendant cleared2015: 2 descendants cleared2024: 7 descendants cleared2016: 3 descendants cleared2012: 2 descendants cleared2013: 2 descendants cleared2014: 5 descendants cleared2022: 2 descendants cleared2017: 3 descendants cleared2018: 3 descendants cleared2019: 2 descendants cleared2020: 3 descendants cleared2025: 8 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared2021: 3 descendants clearedK912980 · Monoscopy Brand 5MM Lock Trocar Sleeve, Modified · Dexide, Inc. · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 10 descendants4 generations forward: 8 descendants5 generations forward: 3 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 K912980 · Monoscopy Brand 5MM Lock Trocar Sleeve, Modified · Dexide, Inc. · 19910+5+10
  1. Root · 1 generation backK912980 Monoscopy Brand 5MM Lock Trocar Sleeve, ModifiedDexide, Inc. · 1991
  2. This deviceK981941 Multaport Cannula Reducer and AccessoriesDexide, Inc. · 1998
  3. Descendant · cites it directly · 59 of its ownK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
  4. Descendant · cites it directly · 58 of its ownK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
  5. Descendant · 2 generations on · 46 of its ownK090902 Spider Single Port Surgical Device, Support Arm Accessory, Model…Transenterix, Inc. · 2009 · Recalled
  6. Descendant · 2 generations on · 43 of its ownK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled
  7. Descendant · 3 generations on · 42 of its ownK120215 Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper…Intuitive Surgical, Inc. · 2012 · Recalled

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

1999: 12008: 22009: 22010: 12011: 42012: 22013: 22014: 52015: 22016: 32017: 32018: 32019: 22020: 32021: 32022: 22023: 32024: 72025: 82026: 3
1999high 8 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 61 · See all
  • K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…Covidien · 2008 · cites it directly59descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K912980Monoscopy Brand 5MM Lock Trocar Sleeve, ModifiedDexide, Inc.1991—
0 (this device)K981941Multaport Cannula Reducer and AccessoriesDexide, Inc.1998—
+1K072814Convenience 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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200820
200920
201010
201140
201220
201320
201450
201520
201630
201730
201830
201920
202030
202130
202220
202330
202470
202580
202630
FIG. 1 — Lineage of K981941, 1991–2026Source: 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 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. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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
*K912980Monoscopy Brand 5MM Lock Trocar Sleeve, Modified
Summary page 1
…18-6995 Phone No.: (817) 589-1454 Lynette Caldwell Director of Quality Assurance Friday, May 29, 1998 Cannula, Reducer and Accessories. Trocar Cannula Dexide, Inc. — K912980 Aesculap — K942053 The “candidate device” is a reusable, stainless stecl Cannula and disposable, single-use reduction seal syste…
Dexide, Inc.1991—
*K942053Aesculap Interchangeable Trocar Instrument Set
Summary page 1
…(817) 589-1454 Lynette Caldwell Director of Quality Assurance Friday, May 29, 1998 Cannula, Reducer and Accessories. Trocar Cannula Dexide, Inc. — K912980 Aesculap — K942053 The “candidate device” is a reusable, stainless stecl Cannula and disposable, single-use reduction seal system that threads into…
Aesculap, Inc.1994—

Also cleared against K912980: 1 other device →

What descends from it? (61)

See all 61

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

NumberDeviceApplicantDecidedDescendants
K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…Covidien200859
K082619Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States200858
K093372Sils Port Model SILSPT15Covidien Lp, Formerly Registered AS Tyco Healthcar20099
K990379Modification to Multaport Cannula, Reducer and AccessoriesDexide, Inc.19990

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K072814 (Covidien, 2008) has gone furthest, with 59 descendants of its own.
  • 1 other device also cites its predicate K912980.

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—

What is it indicated for?

MultAport Cannulas:

The MultAport reusable cannula is used with an AccuPort Seal or Orbital Reducer Seal and Trocar Spike for creating a point of entry for laparoscopic instruments into the abdominal cavity.

AccuPort 5-12mm Seal:

The AccuPort Seal is a single-use device used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments with diameters ranging from 5mm to 12mm.

Orbital Reducer Seal:

The Orbital Reducer is a single use-device used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments of equal and smaller size.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K912980

1 other device cites the same predicate.

  • K152565Auto Suture Locking TrocarCovidien · 2015

More from Dexide, Inc.

38 FDA decisions under this applicant name. See the company

  • K991814Multachoice InstrumentsDexide, Inc. · 1999
  • K990379Modification to Multaport Cannula, Reducer and AccessoriesDexide, Inc. · 1999
  • K981940Multapump Disposable Pump Head and AccessoriesDexide, Inc. · 1998
  • K953611Dexide Endo-Lube KitDexide, Inc. · 1995
  • K944509Dexide Insufflation Tubing with FilterDexide, Inc. · 1995

Recent decisions in GCJ

The GCJ category page

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  • K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation · 2026
  • K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC · 2026

https://510kreport.com/device/K981941 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981941: Multaport Cannula Reducer and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981941

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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