Cleared Traditional

K982836 - CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM

K982836 is an FDA 510(k) clearance for CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM, manufactured by Sims Deltec, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K982836 · Sims Deltec, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
82d
Days
Class 2
Risk

K982836 is an FDA 510(k) clearance for the CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on November 2, 1998 after a review of 82 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 Sims Deltec, Inc. devices

FDA 510(k) Submission Details - K982836

510(k) Number K982836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1998
Decision Date November 02, 1998
Days to Decision 82 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 129d · This submission: 82d
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 604
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K982836.
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
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CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
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