Cleared Traditional

K981747 - BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX

K981747 is an FDA 510(k) clearance for BIOTRANS PRESSURE MONITORING KIT MODEL ..., manufactured by Sunscope Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K981747 · Sunscope Intl., Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 1998
Decision
94d
Days
Class 2
Risk

K981747 is an FDA 510(k) clearance for the BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Sunscope Intl., Inc. (Newport Beach, US). The FDA issued a Cleared decision on August 20, 1998 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - the FDA cardiovascular device 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sunscope Intl., Inc. devices

FDA 510(k) Submission Details - K981747

510(k) Number K981747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1998
Decision Date August 20, 1998
Days to Decision 94 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 125d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRS Device Classification - Class 2, Special Controls

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRS Transducer, Blood-pressure, Extravascular

All 97
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