Cleared Traditional

K820482 - ACCU-RYNGE INSULIN PUMP #SP-250

K820482 is the FDA 510(k) clearance for ACCU-RYNGE INSULIN PUMP #SP-250 by Delta Medical Industries. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K820482 · Delta Medical Industries · General Hospital
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Mar 1982
Decision
32d
Days
Class 2
Risk

K820482 is an FDA 510(k) clearance for the ACCU-RYNGE INSULIN PUMP #SP-250. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Delta Medical Industries (Mchenry, US). The FDA issued a Cleared decision on March 26, 1982 after a review of 32 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 Delta Medical Industries devices

Submission Details

510(k) Number K820482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1982
Decision Date March 26, 1982
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
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 307
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K820482.
IVAC 630 & VOLUMETRIC INFUSION PUMP
K821047 · Y · May 1982
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
OPEN LOOP AMBULATORY INSULIN INFUSION
K820073 · Cardiac Pacemakers, Inc. · Jan 1982
5B SLAVE MODULE SYRINGE PUMP
K813473 · Baxter Healthcare Corp · Jan 1982