Cleared Traditional

SCIMED ENCORE INFLATION DEVICE, MODEL SM2500 (K903503) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903503 · Scimed · Cardiovascular device
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Oct 1990
Decision
67d
Days
Class 2
Risk

K903503 is an FDA 510(k) clearance for the SCIMED ENCORE INFLATION DEVICE, MODEL SM2500. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Scimed (Maple Grove, US). The FDA issued a Cleared decision on October 9, 1990 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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: 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 Scimed devices

Submission Details

510(k) Number K903503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1990
Decision Date October 09, 1990
Days to Decision 67 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 125d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAV Syringe, Balloon Inflation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - MAV Syringe, Balloon Inflation

All 17
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K903503.
MONARCH(TM) INFLATION SYRINGE
K913994 · Merit Medical Systems, Inc. · Feb 1992
CORDIS INFLATOR DEVICE
K912644 · Cordis Corp. · Sep 1991
INFLATION/DEFLATION DEVICE
K904394 · Boston Scientific Corp · Dec 1990
INFLATION PRO II
K895836 · Baxter Healthcare Corp · Dec 1989
SCHNEIDER-SHILEY INFLATION SYRINGES
K861607 · Shiley, Inc. · Jun 1986