Cleared Traditional

K810850 - PERSONAL MEDICATION INFUSER

K810850 is an FDA 510(k) clearance for PERSONAL MEDICATION INFUSER, manufactured by Pacesetter Systems. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K810850

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.

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 597
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