Cleared Traditional

K921756 - ELECTRONIC INSUFFLATOR MODEL 2054.61

K921756 is an FDA 510(k) clearance for ELECTRONIC INSUFFLATOR MODEL 2054.61, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 714-day FDA review.

K921756 · Richard Wolf Medical Instruments Corp. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Mar 1994
Decision
714d
Days
Class 2
Risk

K921756 is an FDA 510(k) clearance for the ELECTRONIC INSUFFLATOR MODEL 2054.61. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 714 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: 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.

FDA 510(k) Submission Details - K921756

510(k) Number K921756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1992
Decision Date March 28, 1994
Days to Decision 714 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
553d slower than avg
Panel avg: 161d · This submission: 714d
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 178
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K921756.
INSUFO-GARD #100-104
K930767 · Acorn Medical, Inc. · Apr 1994
INSUFFLATOR TUBING KIT W/FILTER
K933094 · Inman Medical Corp. · Apr 1994
ADAIR INSUFFLATION AND INSTRUMENTATION CANNULA
K936155 · Micromedical Devices, Inc. · Apr 1994
PRESSURE TUBING AND ACCESSORIES
K922777 · Arbor Technologies, Inc. · Mar 1994
INSUFFLATION TUBING
K924481 · Applied Medical Resources · Mar 1994
INSUFFLATION TUBING STERILE AND NON-STERILE
K935639 · Charles Polo & Co., Inc. · Mar 1994
K921756 · ELECTRONIC INSUFFLATOR MODEL 2054.61
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