Cleared Traditional

K851904 - DATA TRAC ANESTHESIOLOGY RECORDER

K851904 is the FDA 510(k) clearance for DATA TRAC ANESTHESIOLOGY RECORDER by Datascope Corp.. It is a Class 1 General Hospital device (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.

View all Datascope Corp. devices

Submission Details

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.

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

Devices cleared under the same product code (KZD) and FDA review panel - the closest regulatory comparables to K851904.
OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP
K953290 · Olympus America, Inc. · Oct 1995
LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)
K901225 · Abbott Laboratories · Aug 1990
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
SOLUTION ADMINISTRATION SET (#2C0631)
K760505 · Travenol Laboratories, S.A. · Sep 1976