Cleared Traditional

K884534 - PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER

K884534 is an FDA 510(k) clearance for PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER, manufactured by Pall Biomedical Products Co.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K884534

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
Combination Product No
PCCP Authorized No
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.

JPA Device Classification - Class 2, Special Controls

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 145
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K884534.
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K883689 · Ortho Diagnostic Systems, Inc. · Nov 1988
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