# K180683: Certa Dose Pediatric Midazolam 5mg/mL IM Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Certa Dose, Inc.
- Decided: Nov 7, 2018 after 237 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: 1 generation back to K851090 (1985). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851090: Monoject Sterile 1/2 CC & 1CC Syringes W & W/O Nee, Sherwood Medical Co. (1985) Summary page 4.

## Indications for use
The Certa Dose™ Pediatric Midazolam 5 mg/mL intramuscular (IM) Syringe is intended for the delivery of midazolam 5 mg/mL for use in pediatric (non-neonatal) patients up to 30kg in weight.

Source page: https://510kreport.com/device/K180683
Methodology: https://510kreport.com/methodology