Cleared Traditional

K922197 - INSUFFLATOR TUBING KIT

K922197 is the FDA 510(k) clearance for INSUFFLATOR TUBING KIT by O.R. Concepts, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIG) cleared through the Traditional 510(k) pathway after a 501-day FDA review.

K922197 · O.R. Concepts, Inc. · Obstetrics & Gynecology device
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Sep 1993
Decision
501d
Days
Class 2
Risk

K922197 is an FDA 510(k) clearance for the INSUFFLATOR TUBING KIT. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by O.R. Concepts, Inc. (Roanoke, US). The FDA issued a Cleared decision on September 24, 1993 after a review of 501 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1700 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all O.R. Concepts, Inc. devices

Submission Details

510(k) Number K922197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1992
Decision Date September 24, 1993
Days to Decision 501 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
341d slower than avg
Panel avg: 160d · This submission: 501d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIG Insufflator, Hysteroscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1700
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 - HIG Insufflator, Hysteroscopic

All 27
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K922197.
THE KARL STORZ HAMOU ENDOMAT
K936231 · Karl Storz Endoscopy · Jan 1995
CONCEPT UNIVERSAL PUMP SYSTEM
K933873 · Linvatec Corp. · Dec 1994
HYSTEROMED 100
K930912 · Northgate Technologies, Inc. · Oct 1994
THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR
K912498 · KARL STORZ Endoscopy-America, Inc. · Dec 1991
DAVOL SCOPE IRRIGATION SYSTEM
K901288 · C.R. Bard, Inc. · Oct 1990
CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
K900908 · Zimmer, Inc. · May 1990