Cleared Traditional

K992044 - INFUSION DYNAMICS POWER INFUSER MODEL M100B

K992044 is an FDA 510(k) clearance for INFUSION DYNAMICS POWER INFUSER MODEL M100B, manufactured by Infusion Dynamics, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K992044 · Infusion Dynamics, Inc. · General Hospital
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Sep 1999
Decision
83d
Days
Class 2
Risk

K992044 is an FDA 510(k) clearance for the INFUSION DYNAMICS POWER INFUSER MODEL M100B. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Infusion Dynamics, Inc. (Princeton, US). The FDA issued a Cleared decision on September 8, 1999 after a review of 83 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 Infusion Dynamics, Inc. devices

FDA 510(k) Submission Details - K992044

510(k) Number K992044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1999
Decision Date September 08, 1999
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 129d · This submission: 83d
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 541
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K992044.
ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB
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K991437 · Wells Johnson Co. · Aug 1999
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
K992672 · Belmont Instrument Corp. · Aug 1999
WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
K991275 · Mckinley, Inc. · Jul 1999