Cleared Traditional

K893003 - TOCOLYTIC SITE CARE SUP KIT #1001/100A/...

K893003 is the FDA 510(k) clearance for TOCOLYTIC SITE CARE SUP KIT #1001/100A/... by United Medical Systems, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K893003 · United Medical Systems, Inc. · General Hospital
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Jul 1989
Decision
81d
Days
Class 2
Risk

K893003 is an FDA 510(k) clearance for the TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASE. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by United Medical Systems, Inc. (Santa Ana, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital 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 United Medical Systems, Inc. devices

Submission Details

510(k) Number K893003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received April 24, 1989
Decision Date July 14, 1989
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 215
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K893003.
ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K900263 · Arrow Intl., Inc. · Jul 1990
OPTICALLY CLEAR RADIOPAQUE CATHETER
K893546 · Critikon Company, LLC · Nov 1989
PROLONG INTRAVASCULAR CATHETER
K893965 · Baxter Healthcare Corp · Sep 1989
TERUMO SURFLO(R) I.V. CATHETER
K891087 · Terumo Medical Corp. · Jun 1989
SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE
K884325 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1989
CATH-FINDER SYSTEM
K884701 · Pharmacia Deltec, Inc. · Feb 1989