510(k) · Cleared
ClearedCerta Dose Pediatric Midazolam 5mg/mL IM Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Certa Dose, Inc. · PQX Epinephrine Syringe
Cleared on Nov 7, 2018 as substantially equivalent to K851090 (Sherwood Medical Co., 1985) after a 237-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Nov 7, 2018
- Review
- 237 days
- Class
- Class II
- Product code
- PQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851090 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK851090 Monoject Sterile 1/2 CC & 1CC Syringes W & W/O NeeSherwood Medical Co. · 1985 · Recalled
- This deviceK180683 Certa Dose Pediatric Midazolam 5mg/mL IM SyringeCerta Dose, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851090 | Monoject Sterile 1/2 CC & 1CC Syringes W & W/O Nee | Sherwood Medical Co. | 1985 | 1 |
| 0 (this device) | K180683 | Certa Dose Pediatric Midazolam 5mg/mL IM Syringe | Certa Dose, Inc. | 2018 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PQX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K851090 | Monoject Sterile 1/2 CC & 1CC Syringes W & W/O NeeSummary page 4…ulation: Piston Syringe, 21 CFR 880.5860 Regulatory Class: II Product Code: QDM, Midazolam Syringe III. PREDICATE DEVICES Predicate: Monoject 1mL Tuberculin Syringe, K851090 Reference Device: Certa Dose™ PD Epinephrine 1 mg/mL IM/SC Syringe, K160589 IV. DEVICE DESCRIPTION The Certa Dose™ Pediatric… | 1985 |
| † | K160589 | Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K851090.
How does its category compare?
All PQX devicesPQX Epinephrine Syringe: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PQX
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · PQX
Too few PQX 510(k)s in any year since 2007 to give a median.
Recalls per year · PQX
No recall names PQX since 2007.
Adverse event reports per year · PQX
27in 2025
MAUDE reports naming product code PQX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 27 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180683: Certa Dose Pediatric Midazolam 5mg/mL IM Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180683
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026