Cleared Traditional

K870653 - ULTRASOUND LINEAR/SECTOR SCANNER 1100

K870653 is an FDA 510(k) clearance for ULTRASOUND LINEAR/SECTOR SCANNER 1100, manufactured by Pie Data Medical BV. The device is a Class 2 Obstetrics & Gynecology device with product code KNG cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K870653 · Pie Data Medical BV · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
350d
Days
Class 2
Risk

K870653 is an FDA 510(k) clearance for the ULTRASOUND LINEAR/SECTOR SCANNER 1100. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Pie Data Medical BV (Maastricht 6227 Aj, NL). The FDA issued a Cleared decision on February 2, 1988 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2660 - 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. Elevated predicate reliance profile. 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 Pie Data Medical BV devices

FDA 510(k) Submission Details - K870653

510(k) Number K870653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1987
Decision Date February 02, 1988
Days to Decision 350 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
190d slower than avg
Panel avg: 160d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNG Device Classification - Class 2, Special Controls

Product Code KNG Monitor, Ultrasonic, Fetal
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - KNG Monitor, Ultrasonic, Fetal

All 40
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K870653.
UST-974-5 CONVEX TRANSDUCER
K910153 · Ge Medical Systems Information Technologies · Mar 1991
IMEX DOP-TONE II
K901593 · Imex Medical Systems, Inc. · Jul 1990
HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140
K900618 · Huntleigh Technology, Inc. · Apr 1990
HUNTLEIGH DOPCORD, D140
K854267 · Huntleigh Technology, Inc. · Jul 1986
PROGRAMALITH PROGRAMMER
K823242 · Pacesetter Systems · Jan 1983
DOPPLEX-PLB & PXB
K810115 · Huntleigh Technology, Inc. · Jul 1981