Cleared Traditional

K930012 - KAWASUMI LABORATORIES K-CUFF

K930012 is an FDA 510(k) clearance for KAWASUMI LABORATORIES K-CUFF, manufactured by Kawasumi Laboratories Co., Ltd.. The device is a Class 1 General Hospital device with product code KZD cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K930012 · Kawasumi Laboratories Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
344d
Days
Class 1
Risk

K930012 is an FDA 510(k) clearance for the KAWASUMI LABORATORIES K-CUFF. Classified as Infusor, Pressure, For I.v. Bags (product code KZD), Class I - General Controls.

Submitted by Kawasumi Laboratories Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on December 14, 1993 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5420 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K930012

510(k) Number K930012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1993
Decision Date December 14, 1993
Days to Decision 344 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
215d slower than avg
Panel avg: 129d · This submission: 344d
Pathway characteristics
Predicate-based equivalence.

KZD Device Classification - Class 1, General Controls

Product Code KZD Infusor, Pressure, For I.v. Bags
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5420
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 - KZD Infusor, Pressure, For I.v. Bags

All 34
Devices cleared under the same product code (KZD) and FDA review panel - the closest regulatory comparables to K930012.
OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP
K953290 · Olympus America, Inc. · Oct 1995
PRESSURIZER
K951988 · Promedic, Inc. · Jun 1995
PRESSURE INFUSION CUFF
K942933 · Circulatory Technology, Inc. · Aug 1994
ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000
K921168 · Allen Medical Systems, Inc. · Apr 1993
PRESSURE INFUSER
K913751 · Biomedical Dynamics, Inc. · Jan 1992
TECNADYNE SURGI-SQUEEZE INFUSION PUMP
K910926 · Tecnadyne Scientific, Inc. · Aug 1991
K930012 · KAWASUMI LABORATORIES K-CUFF
Download PDF FDA Summary Kawasumi Laboratories…