Cleared Traditional

K851003 - ARTERIAL FILTER AFS-XX /FILTER HOLDER A...

K851003 is an FDA 510(k) clearance for ARTERIAL FILTER AFS-XX /FILTER HOLDER A..., manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K851003 · Gish Biomedical, Inc. · Cardiovascular device
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Jul 1985
Decision
139d
Days
Class 2
Risk

K851003 is an FDA 510(k) clearance for the ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on July 29, 1985 after a review of 139 days - within the typical 510(k) review window.

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: 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K851003

510(k) Number K851003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1985
Decision Date July 29, 1985
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTM Device Classification - Class 2, Special Controls

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 73
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K851003.
GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)
K862068 · Gelman Sciences, Inc. · Aug 1986
SWANK ARTERIAL LINE BLOOD FILTER HF6000
K855066 · Cobe Laboratories, Inc. · Feb 1986
PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE
K853987 · Pall Biomedical Products Co. · Dec 1985
HEPARIN COATED ARTERIAL BLOOD FILTERS
K842813 · American Bentley · Jan 1985
PALL EC PLUS FILTER
K834380 · Pall Biomedical Products Co. · Aug 1984
PALL EC PLUS FILTER W/FILTER SLEEVE
K834382 · Pall Biomedical Products Co. · Aug 1984