Cleared Traditional

K925691 - INSUFFLATION TUBING

K925691 is an FDA 510(k) clearance for INSUFFLATION TUBING, manufactured by Mectra Labs, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K925691 · Mectra Labs, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Sep 1993
Decision
315d
Days
Class 2
Risk

K925691 is an FDA 510(k) clearance for the INSUFFLATION TUBING. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Mectra Labs, Inc. (Bloomfield, US). The FDA issued a Cleared decision on September 23, 1993 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mectra Labs, Inc. devices

FDA 510(k) Submission Details - K925691

510(k) Number K925691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1992
Decision Date September 23, 1993
Days to Decision 315 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 160d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIF Device Classification - Class 2, Special Controls

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIF Insufflator, Laparoscopic

All 119
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K925691.
INFILTUBE
K925558 · Medsurg Industries, Inc. · Mar 1994
INSUFFLATOR CONNECTING FILTER
K923194 · Procedure Products, Inc. · Oct 1993
INSUFFLATOR TUBING/FILTER KIT
K922244 · O.R. Concepts, Inc. · Sep 1993
MEDICAM 900 INSUFFLATOR WITH ACCESSORIES
K921837 · Kirschner Medical Corp. · Feb 1993
SURGIFLATOR
K921264 · W.O.M. World of Medicine GmbH · Oct 1992
MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR
K915694 · Medical Devices, Inc. · Jun 1992