Cleared Traditional

LP-60 LOW PRESSURE INFLATION DEVICE (K910205) - FDA 510(k) Clearance

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

K910205 · Devices For Vascular Intervention, Inc. · Cardiovascular device
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Feb 1991
Decision
40d
Days
Class 2
Risk

K910205 is an FDA 510(k) clearance for the LP-60 LOW PRESSURE INFLATION DEVICE. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Devices For Vascular Intervention, Inc. (Redwood City, US). The FDA issued a Cleared decision on February 25, 1991 after a review of 40 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 Devices For Vascular Intervention, Inc. devices

Submission Details

510(k) Number K910205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1991
Decision Date February 25, 1991
Days to Decision 40 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 125d · This submission: 40d
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 K910205.
10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE
K922573 · Boston Scientific Corp · Dec 1992
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