Cleared Traditional

K091408 - DISPOSABLE PRESSURE TRANSDUCER

K091408 is an FDA 510(k) clearance for DISPOSABLE PRESSURE TRANSDUCER, manufactured by Shenzhen Ant Hi-Tech Industrial Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K091408 · Shenzhen Ant Hi-Tech Industrial Co., Ltd. · Cardiovascular device
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Aug 2009
Decision
98d
Days
Class 2
Risk

K091408 is an FDA 510(k) clearance for the DISPOSABLE PRESSURE TRANSDUCER. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Shenzhen Ant Hi-Tech Industrial Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on August 18, 2009 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - 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 Shenzhen Ant Hi-Tech Industrial Co., Ltd. devices

FDA 510(k) Submission Details - K091408

510(k) Number K091408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2009
Decision Date August 18, 2009
Days to Decision 98 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRS Device Classification - Class 2, Special Controls

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 - DRS Transducer, Blood-pressure, Extravascular

All 102
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