Cleared Traditional

K790597 - SENSOMAT SIDEARM ADAPTER

K790597 is the FDA 510(k) clearance for SENSOMAT SIDEARM ADAPTER by Biochem International, Inc.. It is a Class 1 General & Plastic Surgery device (product code KGZ) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K790597 · Biochem International, Inc. · General & Plastic Surgery device
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Jul 1979
Decision
106d
Days
Class 1
Risk

K790597 is an FDA 510(k) clearance for the SENSOMAT SIDEARM ADAPTER. Classified as Accessories, Catheter (product code KGZ), Class I - General Controls.

Submitted by Biochem International, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1979 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Biochem International, Inc. devices

Submission Details

510(k) Number K790597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1979
Decision Date July 10, 1979
Days to Decision 106 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGZ Accessories, Catheter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGZ Accessories, Catheter

All 9
Devices cleared under the same product code (KGZ) and FDA review panel - the closest regulatory comparables to K790597.
ARROW CATHETER CLAMP
K802367 · Arrow Intl., Inc. · Oct 1980
CONPHAR CATHETER PLUG
K791803 · Conphar, Inc. · Sep 1979
CONPHAR ADAPT-CONNECTS STERILE, NONSTE.
K791806 · Conphar, Inc. · Sep 1979
ADAPTER, CATHETER SHEATH
K781846 · Arrow Intl., Inc. · Dec 1978
PAD, B-D I.V. CATH.
K781854 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1978