Cleared Traditional

K991469 - AWARE PAD

K991469 is an FDA 510(k) clearance for AWARE PAD, manufactured by Aac Consulting Group, Inc.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K991469 · Aac Consulting Group, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
83d
Days
Class 2
Risk

K991469 is an FDA 510(k) clearance for the AWARE PAD. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Aac Consulting Group, Inc. (Bethesda, US). The FDA issued a Cleared decision on July 20, 1999 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software 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 Aac Consulting Group, Inc. devices

FDA 510(k) Submission Details - K991469

510(k) Number K991469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1999
Decision Date July 20, 1999
Days to Decision 83 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 107d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 Radiology devices follow this clearance model.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 567
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K991469.
ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM
K992470 · Advanced Technology Laboratories, Inc. · Aug 1999
SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM
K992046 · Siemens Medical Solutions USA, Inc. · Aug 1999
ULTRASOUND SCANNER, MODEL TYPE 2101
K991937 · B & K Medical A/S · Jul 1999
GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM
K992208 · Ge Medical Systems, Inc. · Jul 1999
AMIB7
K990198 · Alliance Medical, Inc. · Jun 1999
LONGPORT MODEL LDS -1
K990238 · Longport, Inc. · Jun 1999