Cleared Traditional

K872441 - HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR

K872441 is an FDA 510(k) clearance for HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/..., manufactured by Advanced Technology Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DPT cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K872441 · Advanced Technology Laboratories, Inc. · Cardiovascular device
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Feb 1988
Decision
245d
Days
Class 2
Risk

K872441 is an FDA 510(k) clearance for the HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Advanced Technology Laboratories, Inc. (Bothell, US). The FDA issued a Cleared decision on February 19, 1988 after a review of 245 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2120 - 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 Advanced Technology Laboratories, Inc. devices

FDA 510(k) Submission Details - K872441

510(k) Number K872441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1987
Decision Date February 19, 1988
Days to Decision 245 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
120d slower than avg
Panel avg: 125d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPT Device Classification - Class 2, Special Controls

Product Code DPT Probe, Blood-flow, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2120
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 - DPT Probe, Blood-flow, Extravascular

All 36
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K872441.
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