Cleared Traditional

K921963 - DISPOSABLE

K921963 is the FDA 510(k) clearance for DISPOSABLE by Sun Medical, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIF) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K921963 · Sun Medical, Inc. · Obstetrics & Gynecology device
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Sep 1992
Decision
137d
Days
Class 2
Risk

K921963 is an FDA 510(k) clearance for the DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Sun Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on September 11, 1992 after a review of 137 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Sun Medical, Inc. devices

Submission Details

510(k) Number K921963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1992
Decision Date September 11, 1992
Days to Decision 137 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 160d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 82
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K921963.
INFILTUBE
K925558 · Medsurg Industries, Inc. · Mar 1994
INSUFFLATOR TUBING/FILTER KIT
K922244 · O.R. Concepts, Inc. · Sep 1993
MEDICAM 900 INSUFFLATOR WITH ACCESSORIES
K921837 · Kirschner Medical Corp. · Feb 1993
MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR
K915694 · Medical Devices, Inc. · Jun 1992
MODIFICATION MODEL 7201 INSUFFLATOR
K915051 · Northgate Technologies, Inc. · Jun 1992
SYSTEM 3000 ELECTRONIC INSUFFLATOR
K913873 · Cabot Medical Corp. · Mar 1992