Cleared Traditional

K121267 - BT-200V VASCULAR DOPPLER

K121267 is an FDA 510(k) clearance for BT-200V VASCULAR DOPPLER, manufactured by Bistos Co., Ltd.. The device is a Class 2 Radiology device with product code HGM cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K121267 · Bistos Co., Ltd. · Radiology device
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Aug 2012
Decision
98d
Days
Class 2
Risk

K121267 is an FDA 510(k) clearance for the BT-200V VASCULAR DOPPLER. 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 August 2, 2012 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bistos Co., Ltd. devices

FDA 510(k) Submission Details - K121267

510(k) Number K121267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2012
Decision Date August 02, 2012
Days to Decision 98 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
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGM Device Classification - Class 2, Special Controls

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 100
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