510(k) · Cleared

Recalled · Class II · 2023

Innerdyne Step Trocar Expandable Port, Onestep

K961940510(k) TraditionalCleared Jul 10, 199651-day reviewClass II21 CFR 876.1500Recalls 1

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

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

Cleared on Jul 10, 1996 as substantially equivalent to K943253 (Innerdyne Medical, Inc., 1994) and 3 other predicates after a 51-day review. Its family tree reaches back 1 generation to 1994. 68 later devices descend from it. It has been recalled once.

Decided: Jul 10, 1996
Review: 51 days
Class: Class II
Product code: GCJ
Recalls: 1
Predicates: 4

Its longest line of descent runs back 1 generation to K940232 (1994). 4 ancestors in all. 68 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
This deviceK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996
Descendant · cites it directly · 67 of its ownK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
Descendant · 2 generations on · 59 of its ownK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
Descendant · 2 generations on · 58 of its ownK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
Descendant · 3 generations on · 46 of its ownK090902 Spider Single Port Surgical Device, Support Arm Accessory, Model…Transenterix, Inc. · 2009 · Recalled
Descendant · 3 generations on · 43 of its ownK112208 Intutive Surgical DA Vinci Single Site Instruments and AccessoriesIntuitive Surgical, Inc. · 2011 · Recalled

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2001high 8 (2025) · low 0 (2002)2026

Most influential descendants

Showing 5 of 68 · See all

K012539VerastepUnited States Surgical, A Division of Tyco Healthc · 2001 · cites it directly67descendants
K072814Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…Covidien · 2008 · 2 generations on59descendants
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

Generation	Number	Device	Applicant	Decided	Recalls
−1	K940232	Innerdyne Step Trocar Expandable Port, S.T.E.P.	Innerdyne Medical, Inc.	1994	—
0 (this device)	K961940	Innerdyne Step Trocar Expandable Port, Onestep	Innerdyne, Inc.	1996	—
+1	K012539	Verastep	United States Surgical, A Division of Tyco Healthc	2001	—
+2	K072814	Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced…	Covidien	2008	—
+2	K082619	Sils Port, Models SILSPT5, SILSPT12	Covidien Lp, Formerly Registered AS United States	2008	—
+3	K090902	Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002…	Transenterix, Inc.	2009	1
+3	K112208	Intutive Surgical DA Vinci Single Site Instruments and Accessories	Intuitive Surgical, Inc.	2011	12

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2004	1	0
2005	1	0
2006	1	0
2007	1	0
2008	2	0
2009	2	0
2010	2	0
2011	4	0
2012	2	0
2013	3	0
2014	5	0
2015	2	0
2016	3	0
2017	3	0
2018	3	0
2019	2	0
2020	3	0
2021	3	0
2022	2	0
2023	4	0
2024	7	0
2025	8	0
2026	3	0

FIG. 1 — Lineage of K961940, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K943253	Innerdyne Step Trocar Expandable Port, S.T.E.P. Summary page 1 …y adhesives, welds, and mechanical interlocks. The subject InnerDyne, Inc., OneStep® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658). The subject OneStep®device is similar to the referenced predicates in size, function, product di…	Innerdyne Medical, Inc.	1994	—
*	K940232	Innerdyne Step Trocar Expandable Port, S.T.E.P. Summary page 1 …es, welds, and mechanical interlocks. The subject InnerDyne, Inc., OneStep® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658). The subject OneStep®device is similar to the referenced predicates in size, function, product dimensions…	Innerdyne Medical, Inc.	1994	—
*	K950632	Innerdyne Step Trocar Expandable Port, Step Summary page 1 …, and mechanical interlocks. The subject InnerDyne, Inc., OneStep® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658). The subject OneStep®device is similar to the referenced predicates in size, function, product dimensions and indic…	Innerdyne, Inc.	1995	—
*	K950658	Innerdyne Step Trocar Expandable Port, Step: Summary page 1 …cal interlocks. The subject InnerDyne, Inc., OneStep® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658). The subject OneStep®device is similar to the referenced predicates in size, function, product dimensions and indications for _s…	Innerdyne, Inc.	1995	—

Also cleared against K943253: 2 other devices →

What descends from it? (68)

See all 68

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

Number	Device	Applicant	Decided	Descendants
K012539	Verastep	United States Surgical, A Division of Tyco Healthc	2001	67

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 1, 2023	Class II	Z-1387-2023	Process control	Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 4 ancestors has a recall.
Of its descendants, K012539 (United States Surgical, A Division of Tyco Healthc, 2001) has gone furthest, with 67 descendants of its own.
2 other devices also cite its predicate K943253.

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

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

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

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

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 Step ®family of products are intended for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic and operative instruments into the abdominal and thoracic cavities. The device is configured to be used as either a primary or secondary stick.

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/K961940 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961940: Innerdyne Step Trocar Expandable Port, Onestep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961940

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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