Cleared Traditional

K921837 - MEDICAM 900 INSUFFLATOR WITH ACCESSORIES

K921837 is an FDA 510(k) clearance for MEDICAM 900 INSUFFLATOR WITH ACCESSORIES, manufactured by Kirschner Medical Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K921837 · Kirschner Medical Corp. · Obstetrics & Gynecology device
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Feb 1993
Decision
294d
Days
Class 2
Risk

K921837 is an FDA 510(k) clearance for the MEDICAM 900 INSUFFLATOR WITH ACCESSORIES. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on February 5, 1993 after a review of 294 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 Kirschner Medical Corp. devices

FDA 510(k) Submission Details - K921837

510(k) Number K921837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1992
Decision Date February 05, 1993
Days to Decision 294 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
134d slower than avg
Panel avg: 160d · This submission: 294d
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 83
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K921837.
DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET
K935503 · Davol, Inc. · Mar 1994
INFILTUBE
K925558 · Medsurg Industries, Inc. · Mar 1994
INSUFFLATOR TUBING/FILTER KIT
K922244 · O.R. Concepts, Inc. · Sep 1993
MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR
K915694 · Medical Devices, Inc. · Jun 1992
MODIFICATION MODEL 7201 INSUFFLATOR
K915051 · Northgate Technologies, Inc. · Jun 1992
OTT INSUFFLATOR FILTER PLUS/TUBING SET
K914153 · Marlo Surgical Technology · Apr 1992