Cleared Traditional

K830914 - EXTERNAL VALVE FUNCTION BLOCK

K830914 is an FDA 510(k) clearance for EXTERNAL VALVE FUNCTION BLOCK, manufactured by Honeywell, Inc.. The device is a Class 2 Cardiovascular device with product code DRQ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K830914 · Honeywell, Inc. · Cardiovascular device
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Aug 1983
Decision
141d
Days
Class 2
Risk

K830914 is an FDA 510(k) clearance for the EXTERNAL VALVE FUNCTION BLOCK. Classified as Amplifier And Signal Conditioner, Transducer Signal (product code DRQ), Class II - Special Controls.

Submitted by Honeywell, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2060 - 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 Honeywell, Inc. devices

FDA 510(k) Submission Details - K830914

510(k) Number K830914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1983
Decision Date August 12, 1983
Days to Decision 141 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
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRQ Device Classification - Class 2, Special Controls

Product Code DRQ Amplifier And Signal Conditioner, Transducer Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2060
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 - DRQ Amplifier And Signal Conditioner, Transducer Signal

All 13
Devices cleared under the same product code (DRQ) and FDA review panel - the closest regulatory comparables to K830914.
BARD BIOPOTENTIAL AMPLIFIER II
K901358 · C.R. Bard, Inc. · May 1990
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701
K870728 · A&D Engineering, Inc. · Mar 1987
SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE
K864320 · Cordis Corp. · Feb 1987
TRANSDUCER DOME, CAT.#SD-101
K802961 · Sorensen Research · Dec 1980
DISPOSABLE DIAPHRAGM DONE
K803011 · Sorensen Research · Dec 1980
PRESSURE MODULE (MODEL P3)
K761017 · Datascope Corp. · Nov 1976