Cleared Traditional

K981745 - BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX

K981745 is an FDA 510(k) clearance for BIOTRANS REUSABLE SENSOR BASE MODEL NUM..., 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 60-day FDA review.

K981745 · Sunscope Intl., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
60d
Days
Class 2
Risk

K981745 is an FDA 510(k) clearance for the BIOTRANS REUSABLE SENSOR BASE 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 July 17, 1998 after a review of 60 days - a notably fast clearance cycle.

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: 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 Sunscope Intl., Inc. devices

FDA 510(k) Submission Details - K981745

510(k) Number K981745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1998
Decision Date July 17, 1998
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
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
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K981745.
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P
K043065 · Edwards Lifesciences, LLC · Jan 2005
BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP
K983372 · Sunscope Intl., Inc. · Feb 1999
BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX
K981747 · Sunscope Intl., Inc. · Aug 1998
MX960 REUSABLE PRESSURE TRANSDUCER
K961404 · Medex, Inc. · Jun 1996
PERCEPTOR COMPENSATOR MORSE MANIFOLD
K951722 · Namic · Mar 1996
NOVATRANS II
K951129 · Medex, Inc. · Apr 1995