Cleared Traditional

10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE (K922573) - FDA 510(k) Clearance

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

K922573 · Boston Scientific Corp · Cardiovascular device
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Dec 1992
Decision
190d
Days
Class 2
Risk

K922573 is an FDA 510(k) clearance for the 10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on December 8, 1992 after a review of 190 days - an extended review 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: 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 Boston Scientific Corp devices

Submission Details

510(k) Number K922573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1992
Decision Date December 08, 1992
Days to Decision 190 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 125d · This submission: 190d
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 56
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K922573.
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Presto Inflation Device
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ENCORE 26 ADVANTAGE KIT
K140745 · Boston Scientific Corp · Apr 2014
ENCORE 26 ADVANTAGE KIT
K123214 · Boston Scientific Corp · Nov 2012
ENCORE 26 ADVANTAGE KIT
K120694 · Boston Scientific Corp · Apr 2012
INFLATION/DEFLATION DEVICE
K904394 · Boston Scientific Corp · Dec 1990