Cleared Traditional

K881405 - SIEMENS INTRAVAGINAL TRANSDUCER (FDA 510(k) Clearance)

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

K881405 · Siemens Medical Solutions USA, Inc. · Obstetrics & Gynecology device
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Aug 1988
Decision
120d
Days
Class 2
Risk

K881405 is an FDA 510(k) clearance for the SIEMENS INTRAVAGINAL TRANSDUCER. Classified as Transducer, Ultrasonic, Obstetric (product code HGL), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on August 2, 1988 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2960 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K881405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1988
Decision Date August 02, 1988
Days to Decision 120 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 160d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGL Transducer, Ultrasonic, Obstetric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2960
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 Obstetrics & Gynecology devices follow this clearance model.