Cleared Traditional

K884534 - PALL HEPCHEK (TM) HEPARIN ABSORPTION FI...

K884534 is the FDA 510(k) clearance for PALL HEPCHEK (TM) HEPARIN ABSORPTION FI... by Pall Biomedical Products Co.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K884534 · Pall Biomedical Products Co. · Hematology device
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Jan 1989
Decision
88d
Days
Class 2
Risk

K884534 is an FDA 510(k) clearance for the PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Pall Biomedical Products Co. (Glen Cove, US). The FDA issued a Cleared decision on January 24, 1989 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology device 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 Pall Biomedical Products Co. devices

Submission Details

510(k) Number K884534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1988
Decision Date January 24, 1989
Days to Decision 88 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 113d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 Hematology devices follow this clearance model.

Regulatory Peers - JPA System, Multipurpose For In Vitro Coagulation Studies

All 82
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K884534.
HEPARIN ADSORBENT
K912061 · Sigma Diagnostics, Inc. · Jul 1991
COAG-A-MATE - RA4
K900917 · Organon Teknika Corp. · Apr 1990
COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN
K900377 · Baxter Healthcare Corp · Mar 1990
COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE
K885076 · Organon Teknika Corp. · Dec 1988
ORTHO OWREN'S BUFFER
K883689 · Ortho Diagnostic Systems, Inc. · Nov 1988
OWREN'S VERONAL BUFFER
K883484 · Helena Laboratories · Aug 1988