Cleared Traditional

K882106 - PERFUSOR M SYRINGE PUMP

K882106 is the FDA 510(k) clearance for PERFUSOR M SYRINGE PUMP by Burron Medical, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K882106 · Burron Medical, Inc. · General Hospital
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Aug 1988
Decision
85d
Days
Class 2
Risk

K882106 is an FDA 510(k) clearance for the PERFUSOR M SYRINGE PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Burron Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on August 11, 1988 after a review of 85 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 Burron Medical, Inc. devices

Submission Details

510(k) Number K882106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1988
Decision Date August 11, 1988
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 306
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K882106.
BARD INFUSOR PUMP
K883577 · C.R. Bard, Inc. · Nov 1988
BIOSEARCH 3600 ENTRI FEEDING PUMP
K883587 · Biosearch Medical Products, Inc. · Nov 1988
BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI.
K882556 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988
BARD PCA II INFUSION PUMP
K880733 · C.R. Bard, Inc. · Jun 1988
IVAC VOLUMETRIC PUMP - MODEL 590
K875332 · Y · May 1988
HALF HOUR INFUSOR
K880625 · Baxter Healthcare Corp · Apr 1988