Cleared Traditional

K830906 - PULSAMAT MODEL 1050

K830906 is an FDA 510(k) clearance for PULSAMAT MODEL 1050, manufactured by Ferring Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K830906 · Ferring Laboratories, Inc. · General Hospital
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Jun 1983
Decision
86d
Days
Class 2
Risk

K830906 is an FDA 510(k) clearance for the PULSAMAT MODEL 1050. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Ferring Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1983 after a review of 86 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 Ferring Laboratories, Inc. devices

FDA 510(k) Submission Details - K830906

510(k) Number K830906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1983
Decision Date June 15, 1983
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
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 618
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K830906.
PROMINJET PUMP
K832120 · Abbott Laboratories · Aug 1983
ENTERNAL PUMP & ADMIN. SET 430
K831935 · Imed Corp. · Aug 1983
FLO-GARD 6100 VOLUMETRIC INFUSION PUMP
K831258 · Travenol Laboratories, S.A. · Jun 1983
Y-TYPE BACKCHECK MICROBORE EXTEN. SET
K831203 · Abbott Laboratories · Jun 1983
RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE
K831259 · Cardiac Pacemakers, Inc. · May 1983
PCA PUMP
K830452 · Abbott Laboratories · Apr 1983