Cleared Traditional

K851904 - DATA TRAC ANESTHESIOLOGY RECORDER

K851904 is an FDA 510(k) clearance for DATA TRAC ANESTHESIOLOGY RECORDER, manufactured by Datascope Corp.. The device is a Class 1 General Hospital device with product code KZD cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K851904 · Datascope Corp. · General Hospital
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May 1985
Decision
10d
Days
Class 1
Risk

K851904 is an FDA 510(k) clearance for the DATA TRAC ANESTHESIOLOGY RECORDER. Classified as Infusor, Pressure, For I.v. Bags (product code KZD), Class I - General Controls.

Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on May 10, 1985 after a review of 10 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K851904

510(k) Number K851904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1985
Decision Date May 10, 1985
Days to Decision 10 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 129d · This submission: 10d
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 32
Devices cleared under the same product code (KZD) and FDA review panel - the closest regulatory comparables to K851904.
LIFE PAC
K854807 · Lifemed Technologies, Inc. · Apr 1986
THE WOOD PUMP 'OLE RED'
K855054 · T.C. Retigo, Inc. · Mar 1986
PRESSURE INFUSOR #1900
K860084 · Pa Medical Corp. · Mar 1986
BIOCUFF INFUSION BAG PRESSOR
K832377 · Bio-Medical Instruments , Ltd. · Aug 1983
CREST PRESSURE INFUSOR
K822434 · Crest Medical Equipment · Sep 1982
AUTOCUFF (PHOTOS ENCLOSED WITH 510K
K822286 · Partamed, Inc. · Aug 1982
K851904 · DATA TRAC ANESTHESIOLOGY RECORDER
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