Cleared Traditional

K813464 - DISPOSABLE TRANSDUCER

K813464 is the FDA 510(k) clearance for DISPOSABLE TRANSDUCER by Sorensen Research. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K813464 · Sorensen Research · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1982
Decision
27d
Days
Class 2
Risk

K813464 is an FDA 510(k) clearance for the DISPOSABLE TRANSDUCER. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Sorensen Research (Mchenry, US). The FDA issued a Cleared decision on January 7, 1982 after a review of 27 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 Sorensen Research devices

Submission Details

510(k) Number K813464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1981
Decision Date January 07, 1982
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
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 31
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K813464.
FLEX-E1 ECG ELECTRODE
K820579 · Conmedcorp · Apr 1982
BARD CARDIOPULMONARY MONITORING LINES
K820186 · C.R. Bard, Inc. · Feb 1982
NIHON KOHDEN ELECTROCARDIOGRAPH
K813266 · Nihon Kohden America, Inc. · Jan 1982
COBE DISPOSABLE PRESSURE TRANSDUCER
K810637 · Cobe Laboratories, Inc. · Apr 1981
CATHDAMP
K810661 · Medline Industries, Inc. · Mar 1981
CARDIOSCOPE J200
K802179 · Telectronics, Inc. · Nov 1980