Cleared Traditional

K871928 - CARBON DIOXIDE INSUFFLATOR/LAPARO & HI ...

K871928 is the FDA 510(k) clearance for CARBON DIOXIDE INSUFFLATOR/LAPARO & HI ... by Medline Industries, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIF) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K871928 · Medline Industries, Inc. · Obstetrics & Gynecology device
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Nov 1987
Decision
189d
Days
Class 2
Risk

K871928 is an FDA 510(k) clearance for the CARBON DIOXIDE INSUFFLATOR/LAPARO & HI FLOW LASER/. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Englewood, US). The FDA issued a Cleared decision on November 23, 1987 after a review of 189 days - an extended review cycle.

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 Medline Industries, Inc. devices

Submission Details

510(k) Number K871928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1987
Decision Date November 23, 1987
Days to Decision 189 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 160d · This submission: 189d
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 80
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K871928.
NORTHGATE TECHNOLOGIES MODEL 7201 INSUFFLATOR
K905481 · Northgate Technologies, Inc. · Mar 1991
THE DART
K905549 · Dexide, Inc. · Feb 1991
ELECTRONIC INSUFFLATOR, MODEL NO. 2054.60
K882185 · Richard Wolf Medical Instruments Corp. · Jun 1988
MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA
K845021 · Medline Industries, Inc. · May 1985