510(k) Report

510(k) · Cleared

Cleared

Innerdyne Step Trocar Expandable Port, Ministep

K961430510(k) TraditionalCleared May 28, 199643-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

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

Cleared on May 28, 1996 as substantially equivalent to K943253 (Innerdyne Medical, Inc., 1994) and 4 other predicates after a 43-day review. Its family tree reaches back 1 generation to 1994.

Decided
May 28, 1996
Review
43 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K940232 (1994). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 3 other ancestors1994: 1 other ancestorK940232 · Innerdyne Step Trocar Expandable Port, S.T.E.P. · Innerdyne Medical, Inc. · 199419901992199419961998
Other ancestors, by generation 1 generation back: 4 other ancestors K940232 · Innerdyne Step Trocar Expandable Port, S.T.E.P. · Innerdyne Medical, Inc. · 19940
  1. Root · 1 generation backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
  2. This deviceK961430 Innerdyne Step Trocar Expandable Port, MinistepInnerdyne, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K940232Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc.1994—
0 (this device)K961430Innerdyne Step Trocar Expandable Port, MinistepInnerdyne, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199530
FIG. 1 — Lineage of K961430, 1994–1996Source: 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
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What was it cleared against? (6)

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
*K943253Innerdyne Step Trocar Expandable Port, S.T.E.P.
Summary page 1
…adhesives, welds, and mechanical interlocks. The subject InnerDyne, Inc., MiniStep® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658), the Imagyn Microlap Introducer, K943810, and the USSC AutoSuture MiniSite Introducer. The subjec…
Innerdyne Medical, Inc.1994—
*K940232Innerdyne Step Trocar Expandable Port, S.T.E.P.
Summary page 1
…s, welds, and mechanical interlocks. The subject InnerDyne, Inc., MiniStep® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658), the Imagyn Microlap Introducer, K943810, and the USSC AutoSuture MiniSite Introducer. The subject MiniSte…
Innerdyne Medical, Inc.1994—
*K950632Innerdyne Step Trocar Expandable Port, Step
Summary page 1
…and mechanical interlocks. The subject InnerDyne, Inc., MiniStep® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658), the Imagyn Microlap Introducer, K943810, and the USSC AutoSuture MiniSite Introducer. The subject MiniStep® device…
Innerdyne, Inc.1995—
*K950658Innerdyne Step Trocar Expandable Port, Step:
Summary page 1
…al interlocks. The subject InnerDyne, Inc., MiniStep® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658), the Imagyn Microlap Introducer, K943810, and the USSC AutoSuture MiniSite Introducer. The subject MiniStep® device is similar t…
Innerdyne, Inc.1995—
*K943810Imagyn Microlap Introducer
Summary page 1
…., MiniStep® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658), the Imagyn Microlap Introducer, K943810, and the USSC AutoSuture MiniSite Introducer. The subject MiniStep® device is similar to the referenced predicates in size, funct…
Imagyn Medical, Inc.1995—
*—USSC AutoSuture MiniSite Introducer
Named without a submission number
—

Also cleared against K943253: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 5 ancestors has a recall.
  • 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

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?

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.

Also cleared against K943253

2 other devices cite the same predicate.

  • K970754Innerdyne Step Trocar Expanable Port, Open StepInnerdyne, Inc. · 1997
  • K961940Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 19961 recall

More from Innerdyne, Inc.

12 FDA decisions under this applicant name. See the company

  • K992668Innerdyne Radially Expanding Vascular Access System (Revas)Innerdyne, Inc. · 2000
  • K990854Innerdyne Radially Expanding Dilation, Red DeviceInnerdyne, Inc. · 1999
  • K990493Innerdyne Generic Radially Expanding Dilation, G-Red DeviceInnerdyne, Inc. · 1999
  • K982417Innerdyne Step Trocar Expandable Port, StepInnerdyne, Inc. · 1998
  • K980578Innerdyne Radially Expanding Vascular Access System (Heparin Coated)Innerdyne, Inc. · 1998

Recent decisions in GCJ

The GCJ category page

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https://510kreport.com/device/K961430 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961430: Innerdyne Step Trocar Expandable Port, Ministep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961430

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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