510(k) Report

510(k) · Cleared

Cleared

Mini-Port

K992904510(k) TraditionalCleared Oct 5, 199936-day reviewClass I21 CFR 878.4200

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

Taut, Inc. · GBW Catheter, Peritoneal

Cleared on Oct 5, 1999 after a 36-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.

Decided
Oct 5, 1999
Review
36 days
Class
Class I
Product code
GBW
Recalls
None
Predicates
0

8 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2018: 1 descendant cleared2013: 1 descendant cleared2010: 2 descendants cleared2016: 1 descendant cleared2012: 1 descendant cleared1995200020052010201520202025
  1. This deviceK992904 Mini-PortTaut, Inc. · 1999
  2. Descendant · cites it directly · 6 of its ownK070686 Mini Lap InstrumentsMini Lap Technologies, Inc. · 2007
  3. Descendant · 2 generations on · 1 of its ownK113597 Mini-Lap Bipolar Electrocautery DevicesMinilap Technologies · 2012
  4. Descendant · cites it directly · 1 of its ownK070352 Mini Lap Pediatric Instruments with Medusa Clamping SystemMini Lap Technologies, Inc. · 2007
  5. Descendant · 2 generations on · 0 of its ownK172775 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip…Teleflexmedical, Inc. · 2018
  6. Descendant · 2 generations on · 0 of its ownK160149 Miret Grasper, Alligator, Miret Grasper, MarylandMiret Surgical, Inc. · 2016

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2007: 22010: 22012: 12013: 12016: 12018: 1
2007high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 8 · See all
  • K070686Mini Lap InstrumentsMini Lap Technologies, Inc. · 2007 · cites it directly6descendants
  • K113597Mini-Lap Bipolar Electrocautery DevicesMinilap Technologies · 2012 · 2 generations on1descendant
  • K070352Mini Lap Pediatric Instruments with Medusa Clamping SystemMini Lap Technologies, Inc. · 2007 · cites it directly1descendant
  • K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleTeleflexmedical, Inc. · 2018 · 2 generations on0descendants
  • K160149Miret Grasper, Alligator, Miret Grasper, MarylandMiret Surgical, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K992904Mini-PortTaut, Inc.1999—
+1K070686Mini Lap InstrumentsMini Lap Technologies, Inc.2007—
+2K113597Mini-Lap Bipolar Electrocautery DevicesMinilap Technologies2012—
+1K070352Mini Lap Pediatric Instruments with Medusa Clamping SystemMini Lap Technologies, Inc.2007—
+2K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleTeleflexmedical, Inc.2018—
+2K160149Miret Grasper, Alligator, Miret Grasper, MarylandMiret Surgical, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
201020
201210
201310
201610
201810
FIG. 1 — Lineage of K992904, 1999–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GBW? 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
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K070686Mini Lap InstrumentsMini Lap Technologies, Inc.20076
K070352Mini Lap Pediatric Instruments with Medusa Clamping SystemMini Lap Technologies, Inc.20071

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?

  • Of its descendants, K070686 (Mini Lap Technologies, Inc., 2007) has gone furthest, with 6 descendants of its own.

How does its category compare?

All GBW devices

GBW Catheter, Peritoneal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GBW

FDA has decided no GBW device since 2007.

Median 510(k) review, days · GBW

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

Recalls per year · GBW

6in 2016

2007: 12009: 12015: 12016: 62026 (partial year): 1, 1 Class I
2007high 6 (2016) · low 0 (2008)2026

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

Adverse event reports per year · GBW

28in 2023

2007: 12008: 22010: 12011: 12012: 22013: 22014: 12016: 32017: 212018: 102019: 12020: 32021: 82022: 62023: 28
2007high 28 (2023) · low 0 (2009)2025

MAUDE reports naming product code GBW, 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—11
20080—02
20090—10
20100—01
20110—01
20120—02
20130—02
20140—01
20150—10
20160—63
20170—021
20180—010
20190—01
20200—03
20210—08
20220—06
20230—028
20240—00
20250—00
20260—1 (1)—

What is it indicated for?

For use as an abdominal access port during a laparoscopic procedure and the 1-way stopcock for attaching insufflation tubing to maintain pneumoperitoneal pressure.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

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
  • K010007Adapt Laparoscopic Port & Adapt Reducer CapTaut, Inc. · 20013 recalls
  • K003703Taut-Insufflation NeedleTaut, Inc. · 2001

Recent decisions in GBW

The GBW category page

  • K992907IntraducerTaut, Inc. · 19991 recall
  • K972112Intraducer Port SC Catalog#31275,31035,30915, and 31450Taut, Inc. · 1997
  • K961194Antimicrobial Mediastinal Silicone DrainSil-Med Corp. · 1996
  • K960426Medicomp Flexi-Smooth Wound Drainage CatheterMedical Components, Inc. · 1996
  • K942709Mediastinal Silicone DrainsSil-Med Corp. · 1996

https://510kreport.com/device/K992904 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992904: Mini-Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992904

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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