Cleared Traditional

INVASIVE MONITORING KITS (K832907) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K832907 · American Pharmaseal Div. Ahsc · Cardiovascular device
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Jan 1984
Decision
134d
Days
Class 2
Risk

K832907 is an FDA 510(k) clearance for the INVASIVE MONITORING KITS. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by American Pharmaseal Div. Ahsc (Mchenry, US). The FDA issued a Cleared decision on January 10, 1984 after a review of 134 days - within the typical 510(k) review window.

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 American Pharmaseal Div. Ahsc devices

Submission Details

510(k) Number K832907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1983
Decision Date January 10, 1984
Days to Decision 134 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 125d · This submission: 134d
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 18
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K832907.
PRESSURE TRANSDUCER DOME 1295C
K841613 · Hewlett-Packard Co. · Oct 1984
PHYSIOLOGICAL PRESSURE TRANSDUCER 1290C
K840121 · Hewlett-Packard Co. · May 1984
CARDIOFAX ECG 6543
K840274 · Nihon Kohden America, Inc. · Apr 1984
USCI ELECTRONIC MANOMETER
K830093 · C.R. Bard, Inc. · Jan 1983
BARD CARDIOPULMONARY MONITORING LINES
K820186 · C.R. Bard, Inc. · Feb 1982
NIHON KOHDEN ELECTROCARDIOGRAPH
K813266 · Nihon Kohden America, Inc. · Jan 1982