Cleared Traditional

K942238 - I.V. STARTPAK VASCULAR ACCESS START KIT

K942238 is the FDA 510(k) clearance for I.V. STARTPAK VASCULAR ACCESS START KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 General & Plastic Surgery device (product code LRS) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K942238 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
25d
Days
Class 2
Risk

K942238 is an FDA 510(k) clearance for the I.V. STARTPAK VASCULAR ACCESS START KIT. Classified as I.v. Start Kit (product code LRS), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sandy, US). The FDA issued a Cleared decision on June 3, 1994 after a review of 25 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K942238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1994
Decision Date June 03, 1994
Days to Decision 25 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
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 K942238.
AMSINO I.V. START KIT
K050654 · Amsino International, Inc. · May 2005
PERSONAL HEARING SYSTEM
K944041 · Resound Corp. · Dec 1994
IV PREP KIT (NON-STERILE)
K925017 · Customed, Inc. · Aug 1993
IV PREP KIT W/O DRESSING (NON-STERILE)
K925018 · Customed, Inc. · Aug 1993
COLD CD ASP MODULE, ITE
K933041 · Electone, Inc. · Aug 1993
I.V. START KIT, STERILE, DISPOSABLE
K923361 · Trinity Laboratories, Inc. · Jun 1993