Cleared Traditional

NEW OPTIONAL PROBES FOR SSA-90A (K852159) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852159 · Toshiba Medical Systems · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
199d
Days
Class 2
Risk

K852159 is an FDA 510(k) clearance for the NEW OPTIONAL PROBES FOR SSA-90A. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on December 2, 1985 after a review of 199 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA microbiology device 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Toshiba Medical Systems devices

Submission Details

510(k) Number K852159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1985
Decision Date December 02, 1985
Days to Decision 199 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 102d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Microbiology devices follow this clearance model.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 94
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K852159.
PS SYSTEM WITH SD-200 DOPPLER
K861358 · Johnson & Johnson Professionals, Inc. · Jul 1986
7.5 MHZ LINEAR PROBE (ULTRASONIC TRANSDUCER)
K861228 · General Electric Co. · Jul 1986
RT3600(115V) RT3600(220/240V)
K853249 · General Electric Co. · Dec 1985
MODEL 21225A CW COPPLER/IMAGING TRANSDUCER
K852132 · Hewlett-Packard Co. · Aug 1985
3.5 MHZ BIOPSY TRANSDUCER
K812929 · General Electric Co. · Nov 1981
7.5 MHZ WP TRANSDUCER
K810748 · General Electric Co. · Jun 1981