Cleared Traditional

FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING (K933652) - FDA 510(k) Clearance

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

K933652 · Repro-Med Systems, Inc. · General Hospital
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May 1994
Decision
294d
Days
Class 2
Risk

K933652 is an FDA 510(k) clearance for the FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Repro-Med Systems, Inc. (West Cadwell, US). The FDA issued a Cleared decision on May 18, 1994 after a review of 294 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 Repro-Med Systems, Inc. devices

Submission Details

510(k) Number K933652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 28, 1993
Decision Date May 18, 1994
Days to Decision 294 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 129d · This submission: 294d
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 Peers - FRN Pump, Infusion

All 264
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K933652.
PLUM XL INFUSION PUMP
K944733 · Abbott Laboratories · Feb 1995
ABBOTT LTE INFUSION PUMP
K944125 · Abbott Laboratories · Dec 1994
PROVIDER ANNE INFUSER
K922702 · Abbott Laboratories · Jul 1994
BARD APII PUMP
K926385 · C.R. Bard, Inc. · Apr 1994
HI-FLO INFUSION PUMP
K934671 · Abbott Laboratories · Mar 1994
BARD 500ML RESERVOIR HOLDER
K915649 · C.R. Bard, Inc. · Mar 1994