Cleared Traditional

K103545 - BT-350

K103545 is an FDA 510(k) clearance for BT-350, manufactured by Bistos Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K103545 · Bistos Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
162d
Days
Class 2
Risk

K103545 is an FDA 510(k) clearance for the BT-350. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Bistos Co., Ltd. (Brooklyn, US). The FDA issued a Cleared decision on May 13, 2011 after a review of 162 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - 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 Bistos Co., Ltd. devices

FDA 510(k) Submission Details - K103545

510(k) Number K103545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2010
Decision Date May 13, 2011
Days to Decision 162 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 161d · This submission: 162d
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 175
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K103545.
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CIV-OB (PLUS)
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