Cleared Traditional

K871281 - IV START KIT

K871281 is an FDA 510(k) clearance for IV START KIT, manufactured by The Jarid Group, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRS cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K871281 · The Jarid Group, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 1987
Decision
57d
Days
Class 2
Risk

K871281 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 The Jarid Group, Inc. (Wayside, US). The FDA issued a Cleared decision on May 27, 1987 after a review of 57 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 The Jarid Group, Inc. devices

FDA 510(k) Submission Details - K871281

510(k) Number K871281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1987
Decision Date May 27, 1987
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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 K871281.
I.V. START KIT, STERILE, DISPOSABLE
K923361 · Trinity Laboratories, Inc. · Jun 1993
I.V. START KIT
K924811 · Transidyne General Corp. · Jun 1993
IV START KIT
K914475 · Cypress Medical Products, Ltd. · Mar 1992
I.V. START KIT, STERILE, DISPOSABLES
K863712 · Busse Hospital Disposables, Inc. · Oct 1986
I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE
K852375 · Ferris Mfg. Corp. · Jul 1985
CURITY I.V. START KIT
K842898 · The Kendal Co. · Aug 1984