Cleared Traditional

K951167 - EMS I.V. START KIT

K951167 is an FDA 510(k) clearance for EMS I.V. START KIT, manufactured by Emergency Medical Supply, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRS cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K951167 · Emergency Medical Supply, Inc. · General & Plastic Surgery device
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May 1995
Decision
63d
Days
Class 2
Risk

K951167 is an FDA 510(k) clearance for the EMS I.V. START KIT. Classified as I.v. Start Kit (product code LRS), Class II - Special Controls.

Submitted by Emergency Medical Supply, Inc. (Shepherdsville, US). The FDA issued a Cleared decision on May 16, 1995 after a review of 63 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 Emergency Medical Supply, Inc. devices

FDA 510(k) Submission Details - K951167

510(k) Number K951167 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 14, 1995
Decision Date May 16, 1995
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRS Device Classification - Class 2, Special Controls

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 18
Devices cleared under the same product code (LRS) and FDA review panel - the closest regulatory comparables to K951167.
AMSINO I.V. START KIT
K050654 · Amsino International, Inc. · May 2005
INFUSION IV SET
K001879 · Nirvi Intl. USA · Nov 2001
IV START KIT
K963722 · Grand Medical Products · Nov 1996
B. BRAUN IV START KITS
K950184 · B. Braun of America, Inc. · Mar 1995
PERSONAL HEARING SYSTEM
K944041 · Resound Corp. · Dec 1994
SAFESTART VASCULAR ACCESS START KIT
K943941 · Becton Dickinson Vascular Access, Inc. · Oct 1994