# K012646: Terumo 30 Gauge Hypodermic Needle

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Aug 27, 2001 after 14 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 K771203 (1977). 1 ancestor in all.
83 later devices descend from it; 5 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771203: Disp. Hypodermic Needle, Terumo America, Inc. (1977) Summary page 1.
- (no number) BD 30 Gauge (Precision Glide) Hypodermic Needle: named in the summary without a submission number

## Most influential descendants
- K040531: Terumo SURGUARD2 Safety Needle (2004), 67 descendants of its own
- K051865: Terumo Surguard 2 Safety Needle or Similar (2005), 65 descendants of its own
- K113422: Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety Needle (2012), 60 descendants of its own
- K170651: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle (2017), 32 descendants of its own
- K192551: 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle (2020), 14 descendants of its own

## Indications for use
The TERUMO® 30 gauge hypodermic needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. It is intended to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Source page: https://510kreport.com/device/K012646
Methodology: https://510kreport.com/methodology