510(k) Report

510(k) · Cleared

Cleared

Mini Lap Instruments

K070686510(k) TraditionalCleared Apr 5, 200724-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

Mini Lap Technologies, Inc. · OCW Endoscopic Tissue Approximation Device

Cleared on Apr 5, 2007 as substantially equivalent to K992904 (Taut, Inc., 1999) after a 24-day review. Its family tree reaches back 1 generation to 1999. 6 later devices descend from it.

Decided
Apr 5, 2007
Review
24 days
Class
Class II
Product code
OCW
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K992904 (1999). 6 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2010: 2 descendants cleared2018: 1 descendant cleared2016: 1 descendant cleared2012: 1 descendant clearedK992904 · Mini-Port · Taut, Inc. · 19991995200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants K992904 · Mini-Port · Taut, Inc. · 19990
  1. Root · 1 generation backK992904 Mini-PortTaut, Inc. · 1999
  2. This deviceK070686 Mini Lap InstrumentsMini Lap Technologies, Inc. · 2007
  3. Descendant · cites it directly · 1 of its ownK113597 Mini-Lap Bipolar Electrocautery DevicesMinilap Technologies · 2012
  4. Descendant · cites it directly · 0 of its ownK172775 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip…Teleflexmedical, Inc. · 2018
  5. Descendant · cites it directly · 0 of its ownK160149 Miret Grasper, Alligator, Miret Grasper, MarylandMiret Surgical, Inc. · 2016
  6. Descendant · cites it directly · 0 of its ownK132232 Mins Needlescopic Resposable Device SystemMinilap Technologies · 2013
  7. Descendant · cites it directly · 0 of its ownK101101 Mini-TongMini Lap Technologies, Inc. · 2010

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2010: 22012: 12013: 12016: 12018: 1
2010high 2 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 6 · See all
  • K113597Mini-Lap Bipolar Electrocautery DevicesMinilap Technologies · 2012 · cites it directly1descendant
  • K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleTeleflexmedical, Inc. · 2018 · cites it directly0descendants
  • K160149Miret Grasper, Alligator, Miret Grasper, MarylandMiret Surgical, Inc. · 2016 · cites it directly0descendants
  • K132232Mins Needlescopic Resposable Device SystemMinilap Technologies · 2013 · cites it directly0descendants
  • K101101Mini-TongMini Lap Technologies, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K992904Mini-PortTaut, Inc.1999—
0 (this device)K070686Mini Lap InstrumentsMini Lap Technologies, Inc.2007—
+1K113597Mini-Lap Bipolar Electrocautery DevicesMinilap Technologies2012—
+1K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleTeleflexmedical, Inc.2018—
+1K160149Miret Grasper, Alligator, Miret Grasper, MarylandMiret Surgical, Inc.2016—
+1K132232Mins Needlescopic Resposable Device SystemMinilap Technologies2013—
+1K101101Mini-TongMini Lap Technologies, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201210
201310
201610
201810
FIG. 1 — Lineage of K070686, 1999–2018Source: 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 OCW? 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 OCW device

  1. #1 K252400 Endomina EZFuse systemscore 12.0 · 5 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK951173FDA’s K951173 is Manual Surgical Instrument for General Use
Our OCR of the scanned summary read K951173, FDA’s number for Manual Surgical Instrument for General Use (United States Surgical, A Division of Tyco Healthc). Its FDA name has none of the distinctive words the summary uses for the device it names, “MiniSite 2mm Laparoscopic Instruments”. Kept off the family tree.
Summary page 5
…anual Surgical Instruments FBQ, 21 CFR 878.5090 Trocar Predicate Device [21 CFR 807.92(a)(3)} Q o] G e} U.S. Surgical Corp — MiniSite 2mm Laparoscopic Instruments — K951173 U.S. Surgical Corp — MiniPort 2mm - K062326* U.S. Surgical Corp — Versaport trocar with fixation sleeve — K062326 Taut — Adapt P…
United States Surgical, A Division of Tyco Healthc1995—
Kept off the family treeK062326FDA’s K062326 is Autosuture Modified Versaport Trocar with Fixation Sleeve
Our OCR of the scanned summary read K062326, FDA’s number for Autosuture Modified Versaport Trocar with Fixation Sleeve (United States Surgical, A Division of Tyco Healthc). Its FDA name has none of the distinctive words the summary uses for the device it names, “MiniPort 2mm”. Kept off the family tree.
Summary page 5
…5090 Trocar Predicate Device [21 CFR 807.92(a)(3)} Q o] G e} U.S. Surgical Corp — MiniSite 2mm Laparoscopic Instruments — K951173 U.S. Surgical Corp — MiniPort 2mm - K062326* U.S. Surgical Corp — Versaport trocar with fixation sleeve — K062326 Taut — Adapt Pediatric Access Ports K612007 / K992904 Des…
United States Surgical, A Division of Tyco Healthc2006—
Kept off the family treeK612007Adapt Pediatric Access Ports
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 5
…truments — K951173 U.S. Surgical Corp — MiniPort 2mm - K062326* U.S. Surgical Corp — Versaport trocar with fixation sleeve — K062326 Taut — Adapt Pediatric Access Ports K612007 / K992904 Description of the Device {21 CFR 807.92(a)(4)] The MINT LAP Instruments are a family of minimally invasive devices. T…
*K992904Mini-Port
Summary page 5
…K951173 U.S. Surgical Corp — MiniPort 2mm - K062326* U.S. Surgical Corp — Versaport trocar with fixation sleeve — K062326 Taut — Adapt Pediatric Access Ports K612007 / K992904 Description of the Device {21 CFR 807.92(a)(4)] The MINT LAP Instruments are a family of minimally invasive devices. The devices…
Taut, Inc.1999—

Also cleared against K992904: 1 other device →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K113597Mini-Lap Bipolar Electrocautery DevicesMinilap Technologies20121
K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleTeleflexmedical, Inc.20180
K160149Miret Grasper, Alligator, Miret Grasper, MarylandMiret Surgical, Inc.20160
K132232Mins Needlescopic Resposable Device SystemMinilap Technologies20130
K101101Mini-TongMini Lap Technologies, Inc.20100
K093449Mini Lap RetractorsMini Lap Technologies, Inc.20100

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?

  • Its one ancestor has no recall.
  • Of its descendants, K113597 (Minilap Technologies, 2012) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K992904.

How does its category compare?

All OCW devices

OCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · OCW

1in 2025

2007: 52008: 42009: 32010: 42011: 12012: 12013: 22016: 22017: 22018: 22019: 12020: 12021: 32023: 32025: 12026 (partial year): 2
2007high 5 (2007) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCW

133in 2023

2007: 58 days median2008: 70 days median2009: 30 days median2010: 91 days median2021: 221 days median2023: 133 days median
2007high 221 (2021) · low 30 (2009)2026

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

Recalls per year · OCW

3so far in 2026, the most since 2007

2023: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OCW

326in 2025

2007: 92008: 472009: 302010: 102011: 162012: 282013: 22014: 282015: 592016: 742017: 4202018: 4132019: 2912020: 1832021: 1982022: 2352023: 2272024: 2112025: 326
2007high 420 (2017) · low 2 (2013)2025

MAUDE reports naming product code OCW, 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
200755809
2008470047
2009330030
2010491010
20111—016
20121—028
20132—02
20140—028
20150—059
20162—074
20172—0420
20182—0413
20191—0291
20201—0183
202132210198
20220—0235
202331331227
20240—0211
20251—0326
20262—3—

What is it indicated for?

The MINI LAP Instruments are a family of minimally invasive devices with the means to

penetrate soft tissue to access certain areas of the human anatomy. The devices are used

to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia

mesh.

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

Cite this page

510(k) Report. “K070686: Mini Lap Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070686

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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