# K974013: Extension Set with Microbore Tubing, Extension Set with Microbore Tubing and 0.2 U Filter, Extension Set with Microbore

- Pathway: 510(k) (Traditional)
- Applicant: Sims Deltec, Inc.
- Decided: Dec 17, 1997 after 56 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K811463 (1981). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942046: Pharmacia Deltec Extension Set with Anti-Siphon Valve, Pharmacia Deltec, Inc. (1994) Summary page 2.
- K811463: Auto-Syringe Micro Volume Extension Set, Baxter Healthcare Corp (1981) Summary page 2.

## Most influential descendants
- K162219: CADD® Infusion Disposables Portfolio with NRFit™ connectors (2017), 1 descendant of its own
- K211649: PCEA Syringe Set (2021), 0 descendants of its own

## Indications for use
The Extension Set with Anti-Siphon Valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD® pumps. The Extension Set with microbore tubing attaches to the Micro Medication Reservoir for the administration of fluids or medications with the CADD-Micro® pump.

Source page: https://510kreport.com/device/K974013
Methodology: https://510kreport.com/methodology