Cleared Traditional

K863796 - CREATIVE CARE SYSTEMS' IV START KIT

K863796 is an FDA 510(k) clearance for CREATIVE CARE SYSTEMS' IV START KIT, manufactured by American Biomaterials Corp.. The device is a Class 2 General & Plastic Surgery device with product code LRS cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K863796 · American Biomaterials Corp. · General & Plastic Surgery device
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Nov 1986
Decision
60d
Days
Class 2
Risk

K863796 is an FDA 510(k) clearance for the CREATIVE CARE SYSTEMS' IV START KIT. Classified as I.v. Start Kit (product code LRS), Class II - Special Controls.

Submitted by American Biomaterials Corp. (Princeton, US). The FDA issued a Cleared decision on November 28, 1986 after a review of 60 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 American Biomaterials Corp. devices

FDA 510(k) Submission Details - K863796

510(k) Number K863796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1986
Decision Date November 28, 1986
Days to Decision 60 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
55d faster than avg
Panel avg: 115d · This submission: 60d
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 10
Devices cleared under the same product code (LRS) and FDA review panel - the closest regulatory comparables to K863796.
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
I.V. START KIT, STERILE, DISPOSABLES
K863712 · Busse Hospital Disposables, Inc. · Oct 1986
CURITY I.V. START KIT
K842898 · The Kendal Co. · Aug 1984
ARGYLE IV STARTER KIT (W/O DRUG)
K760876 · Sherwood Medical Industries · Dec 1976