Cleared Traditional

K935748 - ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K935748 · Ortho Diagnostic Systems, Inc. · Hematology device
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Apr 1995
Decision
511d
Days
Class 2
Risk

K935748 is an FDA 510(k) clearance for the ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on April 26, 1995 after a review of 511 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K935748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1993
Decision Date April 26, 1995
Days to Decision 511 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
398d slower than avg
Panel avg: 113d · This submission: 511d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 - GJS Test, Time, Prothrombin

All 126
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