# K013087: Single Dose Dispensing Pin, Model 2201

- Pathway: 510(k) (Traditional)
- Applicant: Alaris Medical Systems, Inc.
- Decided: Nov 13, 2001 after 57 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- 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 K790472 (1979). 2 ancestors in all.
12 later devices descend from it; 4 cite it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790472: Burron Vented Needle, National Patent Development Corp. (1979) Summary page 2.
- K934561: One Time Vial Access Spike, Icu Medical, Inc. (1994) Summary page 2.

## Most influential descendants
- K040634: Robertsite Vial Adapter, Model 245700021 (2004), 5 descendants of its own
- K071307: Invirolink  and Inviro Tip Blunt Cannulas, Model 130001, 130501, 140001, 140002, 140003 (2008), 2 descendants of its own
- K072759: VIAL2BAG (2007), 2 descendants of its own
- K140730: VIAL2BAG Direct Connect (2014), 1 descendant of its own
- K121182: Vialok Non-Vented (2012), 1 descendant of its own

## Indications for use
The Single Dose Dispensing Pin is a stand-alone, single use, disposable access device which permits syringe access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies. The Single Dose Dispensing Pin is indicated for use with standard medication vials and needleless syringes for withdrawal and/or injection of fluid.

Source page: https://510kreport.com/device/K013087
Methodology: https://510kreport.com/methodology