Cleared Traditional

K921898 - TAD MODEL #9655

K921898 is an FDA 510(k) clearance for TAD MODEL #9655, manufactured by Loric Technology. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K921898 · Loric Technology · Cardiovascular device
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Nov 1992
Decision
194d
Days
Class 2
Risk

K921898 is an FDA 510(k) clearance for the TAD MODEL #9655. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Loric Technology (Bellengham, US). The FDA issued a Cleared decision on November 2, 1992 after a review of 194 days - an extended review 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: 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 Loric Technology devices

FDA 510(k) Submission Details - K921898

510(k) Number K921898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1992
Decision Date November 02, 1992
Days to Decision 194 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 125d · This submission: 194d
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 105
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K921898.
NOVATRANS II
K951129 · Medex, Inc. · Apr 1995
COBE PATIENT MONITORING PRODUCTS
K921343 · Cobe Cardiovascular, Inc. · Jan 1993
MERITRANS(TM) DISPOSABLE TRANSDUCER
K920977 · Merit Medical Systems, Inc. · Dec 1992
THE PERCEPTOR(TM) STAND ALONE TRANSDUCER
K910764 · North American Instrument Corp. · Apr 1991
SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS
K904777 · Baxter Healthcare Corp · Jan 1991
ADVANCE DISPOSABLE PRESSURE TRANSDUCER
K904601 · Advance Medical Designs, Inc. · Dec 1990