Cleared Traditional

K930012 - KAWASUMI LABORATORIES K-CUFF

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

K930012 · Kawasumi Laboratories Co., Ltd. · General Hospital
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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.

View all Kawasumi Laboratories Co., Ltd. devices

Submission Details

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.

Device Classification

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 7
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
LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)
K901225 · Abbott Laboratories · Aug 1990
DATA TRAC ANESTHESIOLOGY RECORDER
K851904 · Datascope Corp. · May 1985
MX820-5 PRESSURE INFUSOR 500CC MX820-10
K800560 · Medex, Inc. · Apr 1980
VOLUME CONTROL DEVICE VCD-150
K780465 · Sorensen Research · Jun 1978
BLOOD-SOLUTION ADMINISTRATION SET, SURG.
K760483 · Travenol Laboratories, S.A. · Sep 1976