Cleared Traditional

K100885 - FETAL MONITOR MODEL: BT-200T (FDA 510(k) Clearance)

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

K100885 · Bistos Co., Ltd. · Radiology device
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Jun 2010
Decision
69d
Days
Class 2
Risk

K100885 is an FDA 510(k) clearance for the FETAL MONITOR MODEL: BT-200T. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Bistos Co., Ltd. (Paterson, US). The FDA issued a Cleared decision on June 7, 2010 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2740 - 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: 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 Bistos Co., Ltd. devices

Submission Details

510(k) Number K100885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2010
Decision Date June 07, 2010
Days to Decision 69 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 107d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
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 - HGM System, Monitoring, Perinatal

All 213
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