Cleared Traditional

K855054 - THE WOOD PUMP 'OLE RED'

K855054 is an FDA 510(k) clearance for THE WOOD PUMP 'OLE RED', manufactured by T.C. Retigo, Inc.. The device is a Class 1 General Hospital device with product code KZD cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K855054 · T.C. Retigo, Inc. · General Hospital
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Mar 1986
Decision
91d
Days
Class 1
Risk

K855054 is an FDA 510(k) clearance for the THE WOOD PUMP 'OLE RED'. Classified as Infusor, Pressure, For I.v. Bags (product code KZD), Class I - General Controls.

Submitted by T.C. Retigo, Inc. (Marion, US). The FDA issued a Cleared decision on March 18, 1986 after a review of 91 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 T.C. Retigo, Inc. devices

FDA 510(k) Submission Details - K855054

510(k) Number K855054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1985
Decision Date March 18, 1986
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
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 16
Devices cleared under the same product code (KZD) and FDA review panel - the closest regulatory comparables to K855054.
KAWASUMI LABORATORIES K-CUFF
K930012 · Kawasumi Laboratories Co., Ltd. · Dec 1993
LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)
K901225 · Abbott Laboratories · Aug 1990
SURGI SQUEEZ
K894927 · Ethox Corp. · Sep 1989
DATA TRAC ANESTHESIOLOGY RECORDER
K851904 · Datascope Corp. · May 1985
NORFOLK/NORWICH PRESSURE INFUSION BOX
K810954 · Medical Innovations Corp. · Apr 1981
MX820-5 PRESSURE INFUSOR 500CC MX820-10
K800560 · Medex, Inc. · Apr 1980