510(k) · Cleared
ClearedMini Lap Pediatric Instruments with Medusa Clamping System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mini Lap Technologies, Inc. · OCW Endoscopic Tissue Approximation Device
Cleared on Apr 5, 2007 as substantially equivalent to K010007 (Taut, Inc., 2001) and 1 other predicate after a 58-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Apr 5, 2007
- Review
- 58 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K992904 (1999). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK992904 Mini-PortTaut, Inc. · 1999
- This deviceK070352 Mini Lap Pediatric Instruments with Medusa Clamping SystemMini Lap Technologies, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK172775 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip…Teleflexmedical, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleTeleflexmedical, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992904 | Mini-Port | Taut, Inc. | 1999 | — |
| 0 (this device) | K070352 | Mini Lap Pediatric Instruments with Medusa Clamping System | Mini Lap Technologies, Inc. | 2007 | — |
| +1 | K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | Teleflexmedical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
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 K252400 Endomina EZFuse systemscore 12.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K951173 | FDA’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, “U.S. Surgical Corp - MiniSite 2mm Laparoscopic Instruments”. Kept off the family tree. Summary page 5…76.4730 Manual Surgical Instruments o FBQ, 21 CFR 878.5090 Trocar Predicate Device [21 CFR §07.92(a)(3)] o U.S. Surgical Corp - MiniSite 2mm Laparoscopic Instruments — K951173 o U.S. Surgical Corp — MiniPort 2mm - K062326* o U.S. Surgical Corp ~ Versaport trocar with fixation sleeve — K062326 o Stryker —… | 1995 |
| Kept off the family tree | K062326 | FDA’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, “U.S. Surgical Corp — MiniPort 2mm”. Kept off the family tree. Summary page 5…CFR 878.5090 Trocar Predicate Device [21 CFR §07.92(a)(3)] o U.S. Surgical Corp - MiniSite 2mm Laparoscopic Instruments — K951173 o U.S. Surgical Corp — MiniPort 2mm - K062326* o U.S. Surgical Corp ~ Versaport trocar with fixation sleeve — K062326 o Stryker — Pediatric Surgical Instruments — Class 1 devi… | 2006 |
| * | K010007 | Adapt Laparoscopic Port & Adapt Reducer Cap Our OCR of the scanned summary read K012007, FDA’s number for RHS Helmet (Restorative Health Svs, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Taut— Adapt Pediatric Access Ports”. | 2001 |
| * | K992904 | Mini-PortSummary page 5…port trocar with fixation sleeve — K062326 o Stryker — Pediatric Surgical Instruments — Class 1 devices exempt from 510(k) o Taut— Adapt Pediatric Access Ports K012007 / K992904 Description of the Device [21 CFR 807.92(a)}(4)] The MINI LAP Pediatric Instruments with MEDUSA Clamping system are a family of… | 1999 |
| * | — | Stryker — Pediatric Surgical Instruments Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | 2018 | 0 |
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?
How does its category compare?
All OCW devicesOCW 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
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, 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 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The MINI LAP Pediatric Instruments with MEDUSA Clamping system 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, during pediatric surgery.
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/K070352 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070352: Mini Lap Pediatric Instruments with Medusa Clamping System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070352
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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