Cleared Traditional

K820073 - OPEN LOOP AMBULATORY INSULIN INFUSION

K820073 is the FDA 510(k) clearance for OPEN LOOP AMBULATORY INSULIN INFUSION by Cardiac Pacemakers, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K820073 · Cardiac Pacemakers, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1982
Decision
13d
Days
Class 2
Risk

K820073 is an FDA 510(k) clearance for the OPEN LOOP AMBULATORY INSULIN INFUSION. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 25, 1982 after a review of 13 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K820073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1982
Decision Date January 25, 1982
Days to Decision 13 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
116d faster than avg
Panel avg: 129d · This submission: 13d
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 401
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K820073.
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
K820860 · Travenol Laboratories, S.A. · Apr 1982
IVAC MODEL 160 AIR-IN-LINE SENSOR
K820764 · Y · Apr 1982
MODEL AS6B INFUSION PUMP
K813590 · Baxter Healthcare Corp · 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
PERSONAL MEDICATION INFUSER
K810850 · Pacesetter Systems · Nov 1981