Cleared Traditional

K830389 - ACCU-RYNGE PUMP SP-250 (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K830389 · Delta Medical Industries · General Hospital
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Sep 1983
Decision
214d
Days
Class 2
Risk

K830389 is an FDA 510(k) clearance for the ACCU-RYNGE PUMP SP-250. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Delta Medical Industries (Walker, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 214 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 Delta Medical Industries devices

Submission Details

510(k) Number K830389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1983
Decision Date September 12, 1983
Days to Decision 214 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
86d slower than avg
Panel avg: 128d · This submission: 214d
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 847
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