Cleared Traditional

FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER (K970866) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970866 · Georgia Biomedical, Inc. · Obstetrics & Gynecology device
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Jan 1998
Decision
319d
Days
Class 2
Risk

K970866 is an FDA 510(k) clearance for the FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Georgia Biomedical, Inc. (North Attleboro, US). The FDA issued a Cleared decision on January 23, 1998 after a review of 319 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 Georgia Biomedical, Inc. devices

Submission Details

510(k) Number K970866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1997
Decision Date January 23, 1998
Days to Decision 319 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
159d slower than avg
Panel avg: 160d · This submission: 319d
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 176
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K970866.
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