Cleared Traditional

K843538 - PO 2 LYTRODE

K843538 is the FDA 510(k) clearance for PO 2 LYTRODE by Polystan C/O Vitalcor, Inc.. It is a Class 2 Cardiovascular device (product code DRY) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K843538 · Polystan C/O Vitalcor, Inc. · Cardiovascular device
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Oct 1984
Decision
41d
Days
Class 2
Risk

K843538 is an FDA 510(k) clearance for the PO 2 LYTRODE. Classified as Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (product code DRY), Class II - Special Controls.

Submitted by Polystan C/O Vitalcor, Inc. (Ballerup Denmark, US). The FDA issued a Cleared decision on October 18, 1984 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4330 - 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 Polystan C/O Vitalcor, Inc. devices

Submission Details

510(k) Number K843538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1984
Decision Date October 18, 1984
Days to Decision 41 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 125d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4330
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 - DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

All 21
Devices cleared under the same product code (DRY) and FDA review panel - the closest regulatory comparables to K843538.
STAT-SAT
K874839 · Gish Biomedical, Inc. · May 1988
HEMATOCRIT-SATURATION MONITOR HSM-100
K852124 · American Bentley · Sep 1985
COBE SATURATION CELL
K843709 · Cobe Laboratories, Inc. · Oct 1984
OXYGEN CONSUMPTION MONITOR #OCM-0100
K823359 · Bentley Laboratories, Inc. · Jan 1983
IN-LINE OXYGEN MONITORING SYSTEM
K821159 · G.D. Searle and Co. · May 1982