# K160589: Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Certa Dose, Inc.
- Decided: Jan 19, 2017 after 324 days
- Product code: PQX (Epinephrine Syringe)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K822083 (1982). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991758: Monoject Insulin Syringe, The Kendal Co. (1999) Summary page 4.
- K071630: Terumo 31G Thinpro Insulin Syringe, Terumo Medical Corp. (2007) Summary page 4.

## Indications for use
The Certa Dose™ PD Epinephrine 1 mg/mL IM/SC Syringe is intended for healthcare professionals to deliver epinephrine 1 mg/mL via intramuscular or subcutaneous injection for pediatric patients.

Source page: https://510kreport.com/device/K160589
Methodology: https://510kreport.com/methodology