Cleared Traditional

K852159 - NEW OPTIONAL PROBES FOR SSA-90A

K852159 is an FDA 510(k) clearance for NEW OPTIONAL PROBES FOR SSA-90A, manufactured by Toshiba Medical Systems. The device is a Class 2 Microbiology device with product code ITX cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K852159 · Toshiba Medical Systems · Microbiology device
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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

FDA 510(k) Submission Details - K852159

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
Combination Product No
PCCP Authorized No
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.

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 Microbiology devices follow this clearance model.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 204
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K852159.
ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M
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K851526 · Toshiba Medical Systems · Sep 1985