Cleared Traditional

I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE (K852375) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852375 · Ferris Mfg. Corp. · General & Plastic Surgery device
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Jul 1985
Decision
37d
Days
Class 2
Risk

K852375 is an FDA 510(k) clearance for the I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE. Classified as I.v. Start Kit (product code LRS), Class II - Special Controls.

Submitted by Ferris Mfg. Corp. (Burr Ridge, US). The FDA issued a Cleared decision on July 11, 1985 after a review of 37 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 Ferris Mfg. Corp. devices

Submission Details

510(k) Number K852375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received June 04, 1985
Decision Date July 11, 1985
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
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.