510(k) · Cleared
ClearedCerta Dose PD Epinephrine 1mg/mL IM/SC 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 Jan 19, 2017 as substantially equivalent to K991758 (The Kendal Co., 1999) and 1 other predicate after a 324-day review. Its family tree reaches back 3 generations to 1982.
- Decided
- Jan 19, 2017
- Review
- 324 days
- Class
- Class II
- Product code
- PQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K822083 (1982). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK822083 U-100 Insulin SyringeTerumo Medical Corp. · 1982
- 2 generations backK992802 Terumo U-100 Insulin SyringeTerumo Medical Corp. · 1999
- 1 generation backK071630 Terumo 31G Thinpro Insulin SyringeTerumo Medical Corp. · 2007
- This deviceK160589 Certa Dose PD Epinephrine 1mg/mL IM/SC SyringeCerta Dose, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K822083 | U-100 Insulin Syringe | Terumo Medical Corp. | 1982 | — |
| −2 | K992802 | Terumo U-100 Insulin Syringe | Terumo Medical Corp. | 1999 | — |
| −1 | K071630 | Terumo 31G Thinpro Insulin Syringe | Terumo Medical Corp. | 2007 | — |
| 0 (this device) | K160589 | Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe | Certa Dose, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K991758 | Monoject Insulin SyringeSummary page 4…ory Class: II Product Code: PQX, Epinephrine Syringe III. PREDICATE DEVICES Primary: Monoject 3/10mL U-100 Insulin Syringe w/ Attached 29 Gauge x ½” Needle, K991758 Secondary: Terumo® 31G ThinPro Insulin Syringe, K071630 Reference Device: UniTox® Syringe, K123710 Reference Device: BD Flu+ Syri… | 1999 |
| * | K071630 | Terumo 31G Thinpro Insulin SyringeSummary page 4…I. PREDICATE DEVICES Primary: Monoject 3/10mL U-100 Insulin Syringe w/ Attached 29 Gauge x ½” Needle, K991758 Secondary: Terumo® 31G ThinPro Insulin Syringe, K071630 Reference Device: UniTox® Syringe, K123710 Reference Device: BD Flu+ Syringe, K091377 IV. DEVICE DESCRIPTION The Certa Dose™… | 2007 |
| † | K123710 | Unitox Botox Syringe | 2013 |
| † | K091377 | BD Flu+ Syringe | 2009 |
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?
- The line of descent spans 35 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- 3 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K991758.
How does its category compare?
All PQX devicesPQX Epinephrine Syringe: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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™ 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160589 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160589: Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160589
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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