Cleared Traditional

K875315 - I.V. START KITS

K875315 is an FDA 510(k) clearance for I.V. START KITS, manufactured by Ni-Med, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRS cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K875315 · Ni-Med, Inc. · General & Plastic Surgery device
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Feb 1988
Decision
50d
Days
Class 2
Risk

K875315 is an FDA 510(k) clearance for the I.V. START KITS. Classified as I.v. Start Kit (product code LRS), Class II - Special Controls.

Submitted by Ni-Med, Inc. (South Lyon, US). The FDA issued a Cleared decision on February 17, 1988 after a review of 50 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.

FDA 510(k) Submission Details - K875315

510(k) Number K875315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received December 29, 1987
Decision Date February 17, 1988
Days to Decision 50 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 115d · This submission: 50d
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 29
Devices cleared under the same product code (LRS) and FDA review panel - the closest regulatory comparables to K875315.
PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KIT
K926031 · Brigam Medical, Inc. · Jun 1993
IV START KIT CUSTOM SMP # A-Z
K922533 · Specialty Medical Products Co. · Mar 1993
IV START KIT
K914475 · Cypress Medical Products, Ltd. · Mar 1992
TELSTAR PREWIRE SERIES
K871731 · Telstar Electronics, Inc. · Oct 1987
IV START KIT
K871281 · The Jarid Group, Inc. · May 1987
CREATIVE CARE SYSTEMS' IV START KIT
K863796 · American Biomaterials Corp. · Nov 1986
K875315 · I.V. START KITS
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