Cleared Traditional

K905536 - FETAL DOPPLER

K905536 is the FDA 510(k) clearance for FETAL DOPPLER by Toshiba America Medical Systems, In.C. It is a Class 2 Radiology device (product code MAA) cleared through the Traditional 510(k) pathway after a 497-day FDA review.

K905536 · Toshiba America Medical Systems, In.C · Radiology device
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Apr 1992
Decision
497d
Days
Class 2
Risk

K905536 is an FDA 510(k) clearance for the FETAL DOPPLER. Classified as Monitor, Fetal Doppler Ultrasound (product code MAA), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on April 21, 1992 after a review of 497 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2660 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Toshiba America Medical Systems, In.C devices

Submission Details

510(k) Number K905536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1990
Decision Date April 21, 1992
Days to Decision 497 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
390d slower than avg
Panel avg: 107d · This submission: 497d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAA Monitor, Fetal Doppler Ultrasound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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 - MAA Monitor, Fetal Doppler Ultrasound

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