Cleared Traditional

XOMED PATENCY MONITOR (K821373) - FDA 510(k) Clearance

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

K821373 · Xomed, Inc. · Cardiovascular device
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Jul 1982
Decision
59d
Days
Class 2
Risk

K821373 is an FDA 510(k) clearance for the XOMED PATENCY MONITOR. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Xomed, Inc. (Arnold, US). The FDA issued a Cleared decision on July 8, 1982 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - 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 Xomed, Inc. devices

Submission Details

510(k) Number K821373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1982
Decision Date July 08, 1982
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 - DPW Flowmeter, Blood, Cardiovascular

All 24
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K821373.
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG
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NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100
K820742 · Nihon Kohden America, Inc. · Apr 1982
EMIT TOBRAMYCIN CONTROL
K800151 · Syva Co. · Feb 1980
BLOOD FLOWMETER SYSTEM
K780302 · Medtronic Vascular · Apr 1978