Cleared Traditional

K143522 - Presto Inflation Device

K143522 is the FDA 510(k) clearance for Presto Inflation Device by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code MAV) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K143522 · C.R. Bard, Inc. · Cardiovascular device
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Jan 2015
Decision
31d
Days
Class 2
Risk

K143522 is an FDA 510(k) clearance for the Presto Inflation Device. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on January 12, 2015 after a review of 31 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K143522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2014
Decision Date January 12, 2015
Days to Decision 31 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 125d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MAV Syringe, Balloon Inflation

All 26
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K143522.
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
K153038 · Medtronic, Inc. · Apr 2016
basixTOUCH40 Inflation Syringe
K153672 · Merit Medical Systems, Inc. · Jan 2016
Fluent Inflation Device
K152387 · Vascular Solutions, Inc. · Dec 2015
ENCORE 26 ADVANTAGE KIT
K140745 · Boston Scientific Corp · Apr 2014
BASIXTOUCH
K130566 · Merit Medical Systems, Inc. · Jun 2013
ENCORE 26 ADVANTAGE KIT
K123214 · Boston Scientific Corp · Nov 2012