Cleared Traditional

SAFIRA (K230083) - FDA 510(k) Clearance

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

K230083 · Medovate Limited · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2023
Decision
293d
Days
Class 2
Risk

K230083 is an FDA 510(k) clearance for the SAFIRA. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medovate Limited (Girton, GB). The FDA issued a Cleared decision on October 31, 2023 after a review of 293 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medovate Limited devices

Submission Details

510(k) Number K230083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2023
Decision Date October 31, 2023
Days to Decision 293 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 129d · This submission: 293d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Delphi Medical Device Consulting, Inc.
Pamela Papineau

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 235
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K230083.
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Plum Duo™ Infusion System
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K211218 · Carefusion 303, Inc. · Jul 2023
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
K230022 · Baxter Healthcare Corporation · Mar 2023