Cleared Traditional

K844614 - IV START KIT

K844614 is the FDA 510(k) clearance for IV START KIT by Packaging Technologies, Inc.. It is a Class 2 General & Plastic Surgery device (product code LRS) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K844614 · Packaging Technologies, Inc. · General & Plastic Surgery device
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Dec 1984
Decision
22d
Days
Class 2
Risk

K844614 is an FDA 510(k) clearance for the IV START KIT. Classified as I.v. Start Kit (product code LRS), Class II - Special Controls.

Submitted by Packaging Technologies, Inc. (Brea, US). The FDA issued a Cleared decision on December 19, 1984 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5200 - the FDA general and plastic surgery 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 Packaging Technologies, Inc. devices

Submission Details

510(k) Number K844614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1984
Decision Date December 19, 1984
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRS I.v. Start Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.pdf. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LRS I.v. Start Kit

All 9
Devices cleared under the same product code (LRS) and FDA review panel - the closest regulatory comparables to K844614.
COLD CD ASP MODULE, ITE
K933041 · Electone, Inc. · Aug 1993
I.V. START KIT, STERILE, DISPOSABLE
K923361 · Trinity Laboratories, Inc. · Jun 1993
I.V. START KIT, STERILE, DISPOSABLES
K863712 · Busse Hospital Disposables, Inc. · Oct 1986
CURITY I.V. START KIT
K842898 · The Kendal Co. · Aug 1984
ARGYLE IV STARTER KIT (W/O DRUG)
K760876 · Sherwood Medical Industries · Dec 1976