Cleared Traditional

K833477 - INTERSEPT 40 MICRON FILTER

K833477 is the FDA 510(k) clearance for INTERSEPT 40 MICRON FILTER by Extracorporeal Medical Specialities, Inc.. It is a Class 2 Cardiovascular device (product code DTM) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K833477 · Extracorporeal Medical Specialities, Inc. · Cardiovascular device
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Dec 1983
Decision
81d
Days
Class 2
Risk

K833477 is an FDA 510(k) clearance for the INTERSEPT 40 MICRON FILTER. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4260 - 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 Extracorporeal Medical Specialities, Inc. devices

Submission Details

510(k) Number K833477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1983
Decision Date December 27, 1983
Days to Decision 81 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
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4260
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 - DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

All 28
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K833477.
ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX
K851003 · Gish Biomedical, Inc. · Jul 1985
LOW TRAUMA ARTERIAL FILTER H-640
K831507 · C.R. Bard, Inc. · Dec 1983
INTERSEPT 40 MICRON FILTER W/TUBING
K833476 · Extracorporeal Medical Specialities, Inc. · Dec 1983
INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT
K823108 · Extracorporeal Medical Specialities, Inc. · Nov 1982
WILLIAM HARVEY H-625 ARTERIAL FILTER
K820472 · C.R. Bard, Inc. · Mar 1982
TERUMO HOLLOW OXYGENATOR CIRCUIT
K812659 · Terumo Medical Corp. · Dec 1981