Cleared Traditional

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

K964989 is an FDA 510(k) clearance for CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-..., manufactured by Critical Device Corp.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K964989 · Critical Device Corp. · General Hospital
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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

FDA 510(k) Submission Details - K964989

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
Combination Product No
PCCP Authorized No
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.

LHI Device Classification - Class 2, Special Controls

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 89
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K964989.
BAG DECANTER
K972134 · Remington Medical, Inc. · Aug 1997
AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM
K955622 · Baxter Healthcare Corp · May 1997
SAFE-CONNECT VIAL DISPENSING SPIKE
K970789 · Faulding Medical Device Co. · 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