Cleared Traditional

CYTOSAFE NEEDLE (K844904) - FDA 510(k) Clearance

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

K844904 · Baxa Corp., Sub. of Cook Group, Inc. · General Hospital
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Feb 1985
Decision
67d
Days
Class 2
Risk

K844904 is an FDA 510(k) clearance for the CYTOSAFE NEEDLE. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Baxa Corp., Sub. of Cook Group, Inc. (Denver, US). The FDA issued a Cleared decision on February 22, 1985 after a review of 67 days - a notably fast clearance cycle.

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: 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 Baxa Corp., Sub. of Cook Group, Inc. devices

Submission Details

510(k) Number K844904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1984
Decision Date February 22, 1985
Days to Decision 67 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 129d · This submission: 67d
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 K844904.
MODIFIED SLIDING RECONSTITUTION DEVICE
K884626 · Baxter Healthcare Corp · Nov 1988
SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST
K853830 · Travenol Laboratories, S.A. · Nov 1985
VIAL VENT FILTER
K852467 · Baxter Healthcare Corp · Oct 1985
TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP
K844340 · Travenol Laboratories, S.A. · Jan 1985