Cleared Traditional

K871609 - ULTRASOUND TRANSDUCER SHEATHS, STERILE

K871609 is an FDA 510(k) clearance for ULTRASOUND TRANSDUCER SHEATHS, manufactured by Amedic USA. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K871609 · Amedic USA · Radiology device
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Jul 1987
Decision
82d
Days
Class 2
Risk

K871609 is an FDA 510(k) clearance for the ULTRASOUND TRANSDUCER SHEATHS, STERILE. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Amedic USA (Phoenix, US). The FDA issued a Cleared decision on July 15, 1987 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 Amedic USA devices

FDA 510(k) Submission Details - K871609

510(k) Number K871609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1987
Decision Date July 15, 1987
Days to Decision 82 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 107d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 335
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K871609.
ADMS TRANSRECTAL 7.5 MHZ PROBE
K870967 · Diasonics, Inc. · Sep 1987
3.0 MHZ PHASED ARRAY SCANHEAD W/2.0 MHZ SIDEARM CW
K871432 · Advanced Technology Laboratories, Inc. · Aug 1987
SONOLAYER - V, SSA-100A.
K863269 · Toshiba Medical Systems · Jul 1987
7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE
K870748 · Philips Ultrasound, Inc. · Apr 1987
TRT TRANS-RECTAL TRANSDUCER
K870038 · Advanced Technology Laboratories, Inc. · Mar 1987
7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12
K863708 · Siemens Medical Solutions USA, Inc. · Mar 1987