Cleared Traditional

K983005 - PERFUSOR COMPACT

K983005 is an FDA 510(k) clearance for PERFUSOR COMPACT, manufactured by B.Braun Medical, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K983005 · B.Braun Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
160d
Days
Class 2
Risk

K983005 is an FDA 510(k) clearance for the PERFUSOR COMPACT. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Carrollton, US). The FDA issued a Cleared decision on February 4, 1999 after a review of 160 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 B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K983005

510(k) Number K983005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1998
Decision Date February 04, 1999
Days to Decision 160 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
31d slower than avg
Panel avg: 129d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 582
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K983005.
PAIN CONTROL INFUSION PUMP
K990101 · Sgarlato Laboratories, Inc. · Mar 1999
SABRATEK 4040 INFUSION PUMP
K980751 · Sabratek Corp. · Feb 1999
DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
K990259 · Disetronic Medical Systems · Feb 1999
ABBOTT PLUM A+ INFUSION PUMP
K982159 · Abbott Laboratories · Jan 1999
VARIABLE PRESSURE SYRINGE PUMP
K974332 · Alaris Medical Systems, Inc. · Dec 1998
MELODIE INFUSION PUMP
K980378 · Compagnie DE Developpement Aguettant · Dec 1998