Cleared Traditional

K932188 - SAFESET RESERVOIR

K932188 is an FDA 510(k) clearance for SAFESET RESERVOIR, manufactured by Abbott Laboratories. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K932188 · Abbott Laboratories · Cardiovascular device
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Oct 1993
Decision
172d
Days
Class 2
Risk

K932188 is an FDA 510(k) clearance for the SAFESET RESERVOIR. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 25, 1993 after a review of 172 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K932188

510(k) Number K932188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1993
Decision Date October 25, 1993
Days to Decision 172 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 125d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - KRA Catheter, Continuous Flush

All 130
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K932188.
SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER
K945593 · Scimed Life Systems, Inc. · Jan 1995
SCIMED(R) VENTURE(TM) INFUSION CATHETER
K931335 · Scimed Life Systems, Inc. · Jul 1994
SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETER
K932616 · Scimed Life Systems, Inc. · Dec 1993
ZEPHYR INFUSION CATHETER
K921247 · Target Therapeutics · Jun 1993
SELECTIVE INFUSION II CATHETER
K914751 · Advanced Cardiovascular Systems, Inc. · May 1993
SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
K924661 · Baxter Healthcare Corp · Apr 1993