Cleared Traditional

K242536 - TauTona Pneumoperitoneum Assist Device (TPAD) (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence.

K242536 · Tautona Group · Obstetrics & Gynecology device
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Oct 2024
Decision
50d
Days
Class 2
Risk

K242536 is an FDA 510(k) clearance for the TauTona Pneumoperitoneum Assist Device (TPAD). Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Tautona Group (Redwood City, US). The FDA issued a Cleared decision on October 15, 2024 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tautona Group devices

Submission Details

510(k) Number K242536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2024
Decision Date October 15, 2024
Days to Decision 50 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 160d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04392635 Completed Interventional

Device to Assist With Abdominal Access During Laparoscopic Surgery

Pilot Study to Establish Safety and Ease of Use of a TauTona Pneumoperitoneum Assist Device (TPAD) for Laparoscopic Surgery

31
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Laparoscopic Surgery
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator James R Korndorffer Jr, MD MHPE FACS
Sponsor Stanford University
Started 2022-06-20 → Primary completion 2024-06-17
Primary outcome
Surgeon Satisfaction Survey
Secondary outcome
Time From Incision for Veress Needle Insertion to Start of Insufflation
View full study on ClinicalTrials.gov

Regulatory Peers - HIF Insufflator, Laparoscopic

All 176
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K242536.
Insufflator (OPTO-IFL1000)
K252318 · Guangdong Optomedic Technologies, Inc. · Apr 2026
ENDOFLATOR +
K250388 · Karl Storz SE & CO. KG · Sep 2025
AirSurgN Insufflator (10030/AirSurgN)
K242772 · Smartsurgn, Inc. · Apr 2025
High Flow Insufflation Unit (UHI-4)
K243527 · Olympus Medical Systems Corporation · Jan 2025
VereSee Optical Veres Needle System
K232464 · Freyja Healthcare, LLC · May 2024
EVA15 insufflator
K232902 · Palliare , Ltd. · May 2024