Cleared Traditional

CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5) (K964989) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964989 · Critical Device Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 1997
Decision
110d
Days
Class 2
Risk

K964989 is an FDA 510(k) clearance for the CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5). Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Critical Device Corp. (Brea, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 110 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Critical Device Corp. devices

Submission Details

510(k) Number K964989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1996
Decision Date April 02, 1997
Days to Decision 110 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
19d faster than avg
Panel avg: 129d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 General Hospital devices follow this clearance model.

Regulatory Peers - LHI Set, I.v. Fluid Transfer

All 64
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K964989.
VIAL-MATE RECONSTITUTION DEVICE (2B8071)
K973654 · Baxter Healthcare Corp · Oct 1997
AUTOMIX 3+3/AS COMPOUNDER SYSTEM
K961008 · Baxter Healthcare Corp · Oct 1997
AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM
K955622 · Baxter Healthcare Corp · May 1997
COMBIPROT EMERGENCY ENFUSION DEVICE
K970359 · B.Braun Medical, Inc. · Mar 1997
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)
K960466 · Abbott Laboratories · May 1996
FORMULATION PREPARATION DEVICE
K955398 · B.Braun Medical, Inc. · Apr 1996