Cleared Abbreviated

K021988 - MEDRAD CONTINUUM MR COMPATIBLE INFUSION...

K021988 is the FDA 510(k) clearance for MEDRAD CONTINUUM MR COMPATIBLE INFUSION... by Medrad, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Abbreviated 510(k) pathway after a 72-day FDA review.

K021988 · Medrad, Inc. · General Hospital
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Aug 2002
Decision
72d
Days
Class 2
Risk

K021988 is an FDA 510(k) clearance for the MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on August 29, 2002 after a review of 72 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Medrad, Inc. devices

Submission Details

510(k) Number K021988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2002
Decision Date August 29, 2002
Days to Decision 72 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 129d · This submission: 72d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.

Regulatory Consultant

Citech
ROBERT MOSENKIS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRN Pump, Infusion

All 444
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K021988.
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
K024084 · Abbott Laboratories · Dec 2002
PARAGON INFUSION SYSTEM WITH BOLUS
K023827 · I-Flow Corp. · Dec 2002
SOAKER CATHETER
K022869 · I-Flow Corp. · Sep 2002
PERFUSOR COMPACT WITH FM SYSTEM
K022575 · B.Braun Medical, Inc. · Aug 2002
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
K021350 · Abbott Laboratories · May 2002
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
K020947 · Smith & Nephew, Inc. · Apr 2002

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.