Cleared Traditional

K884823 - TRANSPAC(R) II, DISPOSABLE TRANSDUCER

K884823 is an FDA 510(k) clearance for TRANSPAC II, manufactured by Abbott Laboratories. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 592-day FDA review.

K884823 · Abbott Laboratories · Neurology device
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Jul 1990
Decision
592d
Days
Class 2
Risk

K884823 is an FDA 510(k) clearance for the TRANSPAC(R) II, DISPOSABLE TRANSDUCER. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 3, 1990 after a review of 592 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - the FDA neurology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K884823

510(k) Number K884823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1988
Decision Date July 03, 1990
Days to Decision 592 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
443d slower than avg
Panel avg: 149d · This submission: 592d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWM Device Classification - Class 2, Special Controls

Product Code GWM Device, Monitoring, Intracranial Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWM Device, Monitoring, Intracranial Pressure

All 82
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K884823.
CAMINO VENTRICULAR TRANSDUCER ACCESSORY
K930221 · Camino Laboratories, Inc. · Apr 1993
MODEL 704
K912139 · Ivy Biomedical Systems, Inc. · Mar 1992
VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM
K914735 · Camino Laboratories, Inc. · Jan 1992
PMT SUBARACHNOID SCREW, MODEL NO.1350-2
K883115 · Pmt Corp. · Aug 1988
VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H
K881183 · Camino Laboratories, Inc. · May 1988
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
K853770 · Codman & Shurtleff, Inc. · Oct 1986