Cleared Traditional

K875371 - KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH...

K875371 is an FDA 510(k) clearance for KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH..., manufactured by Kontron Instruments, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGL cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K875371 · Kontron Instruments, Inc. · Obstetrics & Gynecology device
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Mar 1988
Decision
84d
Days
Class 2
Risk

K875371 is an FDA 510(k) clearance for the KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM. Classified as Transducer, Ultrasonic, Obstetric (product code HGL), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Everett, US). The FDA issued a Cleared decision on March 24, 1988 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kontron Instruments, Inc. devices

FDA 510(k) Submission Details - K875371

510(k) Number K875371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1987
Decision Date March 24, 1988
Days to Decision 84 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
76d faster than avg
Panel avg: 160d · This submission: 84d
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 18
Devices cleared under the same product code (HGL) and FDA review panel - the closest regulatory comparables to K875371.
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KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
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ANNULAR ARRAY SCANHEAD
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BIOPSY NEEDLE GUIDE ATTACHMENT
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280SL IMAGING SYSTEM TRANVAGINAL PROBES
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