Cleared Traditional

K990083 - CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER

K990083 is an FDA 510(k) clearance for CADD ADMINISTRATION SET, manufactured by Sims Deltec, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K990083 · Sims Deltec, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
32d
Days
Class 2
Risk

K990083 is an FDA 510(k) clearance for the CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED S.... Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 12, 1999 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 880.5440 - 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 - K990083

510(k) Number K990083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1999
Decision Date February 12, 1999
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 805
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K990083.
FREE FLOW SAFETY DEVICE, MODEL MG 245052
K990288 · Teva Medical, Ltd. · Feb 1999
KVO CHECK VALVE ACCESSORY, MODEL EV-0001
K984441 · I-Flow Corp. · Feb 1999
BURETROL SOLUTION SETS
K984381 · Baxter Healthcare Corp · Feb 1999
COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105
K983411 · Valnet Medical Corp. · Feb 1999
PARAGON BASAL/BOLUS ADMINISTRATION SET
K984063 · I-Flow Corp. · Feb 1999
PARAGON INFUSION
K984146 · I-Flow Corp. · Feb 1999