Cleared Traditional

K151482 - BCR-30-min BI and RBIP-ST30 Readout Acc...

K151482 is an FDA 510(k) clearance for BCR-30-min BI and RBIP-ST30 Readout Acc..., manufactured by Bcr Diagnostics, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K151482 · Bcr Diagnostics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
269d
Days
Class 2
Risk

K151482 is an FDA 510(k) clearance for the BCR-30-min BI™ and RBIP-ST30™ Readout Accessory. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Bcr Diagnostics, Inc. (Phoenix, US). The FDA issued a Cleared decision on February 26, 2016 after a review of 269 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Bcr Diagnostics, Inc. devices

FDA 510(k) Submission Details - K151482

510(k) Number K151482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2015
Decision Date February 26, 2016
Days to Decision 269 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 129d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRC Device Classification - Class 2, Special Controls

Product Code FRC Indicator, Biological Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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 General Hospital devices follow this clearance model.

Regulatory Peers - FRC Indicator, Biological Sterilization Process

All 148
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