Cleared Traditional

K904394 - INFLATION/DEFLATION DEVICE

K904394 is an FDA 510(k) clearance for INFLATION/DEFLATION DEVICE, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K904394 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
69d
Days
Class 2
Risk

K904394 is an FDA 510(k) clearance for the INFLATION/DEFLATION DEVICE. 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 3, 1990 after a review of 69 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K904394

510(k) Number K904394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1990
Decision Date December 03, 1990
Days to Decision 69 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 125d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAV Device Classification - Class 2, Special Controls

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 42
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K904394.
CONDOR DIGITAL INFLATION SYRINGE
K904954 · Professional Medical Services · Jan 1991
MORSE BALLOON INFLATION DEVICE
K904275 · North American Instrument Corp. · Jan 1991
DISPOSABLE INFLATION GAUGE
K902695 · Cook Urological, Inc. · Dec 1990
CATHETER BALLOON DILATOR PRESSURE GAUGE
K895511 · Argon Medical Corp. · Feb 1990
ACS INDEFLATOR XX
K896849 · Advanced Cardiovascular Systems, Inc. · Feb 1990
INFLATION PRO II
K895836 · Baxter Healthcare Corp · Dec 1989