Cleared Traditional

K910764 - THE PERCEPTOR(TM) STAND ALONE TRANSDUCER

K910764 is the FDA 510(k) clearance for THE PERCEPTOR(TM) STAND ALONE TRANSDUCER by North American Instrument Corp.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K910764 · North American Instrument Corp. · Cardiovascular device
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Apr 1991
Decision
81d
Days
Class 2
Risk

K910764 is an FDA 510(k) clearance for the THE PERCEPTOR(TM) STAND ALONE TRANSDUCER. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by North American Instrument Corp. (Glens Falls, US). The FDA issued a Cleared decision on April 22, 1991 after a review of 81 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 North American Instrument Corp. devices

Submission Details

510(k) Number K910764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1991
Decision Date April 22, 1991
Days to Decision 81 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 85
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K910764.
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
SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS
K904777 · Baxter Healthcare Corp · Jan 1991
ADVANCE DISPOSABLE PRESSURE TRANSDUCER
K904601 · Advance Medical Designs, Inc. · Dec 1990
MORSE DT MANIFOLD
K902472 · North American Instrument Corp. · Aug 1990