Cleared Traditional

K843620 - SCANHEADS-ACCESS 10PV, BIOSTATIC

K843620 is an FDA 510(k) clearance for SCANHEADS-ACCESS 10PV, manufactured by Advanced Technology Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K843620 · Advanced Technology Laboratories, Inc. · Cardiovascular device
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Mar 1985
Decision
179d
Days
Class 2
Risk

K843620 is an FDA 510(k) clearance for the SCANHEADS-ACCESS 10PV, BIOSTATIC. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Advanced Technology Laboratories, Inc. (Bellevue, US). The FDA issued a Cleared decision on March 12, 1985 after a review of 179 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - 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 - K843620

510(k) Number K843620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1984
Decision Date March 12, 1985
Days to Decision 179 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
54d slower than avg
Panel avg: 125d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOP Device Classification - Class 2, Special Controls

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 - JOP Transducer, Ultrasonic

All 54
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K843620.
Q-DOP
K843058 · Quinton, Inc. · Apr 1985
CARDIAC SECTOR PROBE 3.5. MHZ
K850145 · Siemens Medical Solutions USA, Inc. · Apr 1985
CARDIAC SECTOR PROBE 5.0 MHZ
K850216 · Siemens Medical Solutions USA, Inc. · Apr 1985
SCANHEADS ACCESS 10 10PV B10
K843953 · Advanced Technology Laboratories, Inc. · Mar 1985
ACCESS C
K843911 · Advanced Technology Laboratories, Inc. · Mar 1985
ACCESS & 72X ULTRASOUND SCANHEAD UM4
K843131 · Advanced Technology Laboratories, Inc. · Dec 1984