Cleared Traditional

K810850 - PERSONAL MEDICATION INFUSER

K810850 is the FDA 510(k) clearance for PERSONAL MEDICATION INFUSER by Pacesetter Systems. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K810850 · Pacesetter Systems · General Hospital
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Nov 1981
Decision
221d
Days
Class 2
Risk

K810850 is an FDA 510(k) clearance for the PERSONAL MEDICATION INFUSER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Pacesetter Systems (Mchenry, US). The FDA issued a Cleared decision on November 6, 1981 after a review of 221 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 Pacesetter Systems devices

Submission Details

510(k) Number K810850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1981
Decision Date November 06, 1981
Days to Decision 221 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 129d · This submission: 221d
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 443
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K810850.
OPEN LOOP AMBULATORY INSULIN INFUSION
K820073 · Cardiac Pacemakers, Inc. · Jan 1982
5B SLAVE MODULE SYRINGE PUMP
K813473 · Baxter Healthcare Corp · Jan 1982
FLO-GARD 8000 INFUSION PUMP SYSTEM
K813403 · Travenol Laboratories, S.A. · Dec 1981
PORTABLE LIDOCAINE INFUSION PUMP
K812917 · Cardiac Pacemakers, Inc. · Nov 1981
IMED MODEL 970 & 975 VOL. INFUSION PUMP
K812823 · Imed Corp. · Oct 1981
PRESSURE DISC COMPONENT FOR ACCUSET
K812824 · Imed Corp. · Oct 1981