Cleared Traditional

K881405 - SIEMENS INTRAVAGINAL TRANSDUCER

K881405 is an FDA 510(k) clearance for SIEMENS INTRAVAGINAL TRANSDUCER, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGL cleared through the Traditional 510(k) pathway after a 120-day FDA review.

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

FDA 510(k) Submission Details - K881405

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
Combination Product No
PCCP Authorized No
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.

HGL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HGL Transducer, Ultrasonic, Obstetric

All 22
Devices cleared under the same product code (HGL) and FDA review panel - the closest regulatory comparables to K881405.
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
K895647 · Advanced Technology Laboratories, Inc. · Dec 1989
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
K895123 · Advanced Technology Laboratories, Inc. · Nov 1989
HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER
K895026 · Hewlett-Packard Co. · Nov 1989
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
K875334 · Kontron Instruments, Inc. · Mar 1988
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
K875371 · Kontron Instruments, Inc. · Mar 1988
ANNULAR ARRAY SCANHEAD
K871856 · Advanced Technology Laboratories, Inc. · Aug 1987