Cleared Traditional

K083019 - GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR...

K083019 is the FDA 510(k) clearance for GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR... by Hospira, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K083019 · Hospira, Inc. · General Hospital
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Oct 2008
Decision
13d
Days
Class 2
Risk

K083019 is an FDA 510(k) clearance for the GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on October 22, 2008 after a review of 13 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 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 Hospira, Inc. devices

Submission Details

510(k) Number K083019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2008
Decision Date October 22, 2008
Days to Decision 13 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 129d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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

Underwriters Laboratories, Inc.
NED DEVINE

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 370
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K083019.
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K100798 · Medrad, Inc. · Jun 2010
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K083689 · B.Braun Medical, Inc. · Jul 2009
PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K081412 · Hospira, Inc. · Dec 2008
MEDRAD INTEGO PET INFUSION SYSTEM
K080297 · Medrad, Inc. · Jun 2008
MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY
K073051 · Medrad, Inc. · May 2008
HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391
K070398 · Hospira, Inc. · Apr 2007

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.