# K033575: One.Click Needle

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Feb 9, 2004 after 89 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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 K973899 (1997). 1 ancestor in all.
43 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973899: Unifine Pentips, Owen Mumford USA, Inc. (1997) Summary page 1.

## Most influential descendants
- K080904: Feel-Fine Insulin Pen Needle (2008), 30 descendants of its own
- K112332: Fine Ject Insulin Pen Needle (2012), 21 descendants of its own
- K120690: Insulin Pen Needle (2012), 20 descendants of its own
- K133059: Insulin Pen Needle (2014), 18 descendants of its own
- K063466: Top Fine (2007), 11 descendants of its own

## Indications for use
The one.click needle is a sterile, single-packed, disposable hypodermic single lumen needle designed for use with a multidose pen injection device, the one.click auto-injector, for the subcutaneous injection of fluid drug products.

Source page: https://510kreport.com/device/K033575
Methodology: https://510kreport.com/methodology