510(k) · Cleared
ClearedPowerPAK Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vault Paragon Group, Inc. · MEG Syringe, Antistick
Cleared on Jan 25, 2023 as substantially equivalent to K023752 (Bd, 2003) after a 376-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Jan 25, 2023
- Review
- 376 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980069 (1998). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK980069 Vanishpoint SyringeRetractable Technologies, Inc. · 1998
- 1 generation backK023752 BD Integra SyringeBd · 2003 · Recalled
- This deviceK220114 PowerPAK SyringeVault Paragon Group, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK250847 VaporShieldVault Paragon Group, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250847VaporShieldVault Paragon Group, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980069 | Vanishpoint Syringe | Retractable Technologies, Inc. | 1998 | — |
| −1 | K023752 | BD Integra Syringe | Bd | 2003 | 2 |
| 0 (this device) | K220114 | PowerPAK Syringe | Vault Paragon Group, Inc. | 2023 | — |
| +1 | K250847 | VaporShield | Vault Paragon Group, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 MEG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MEG device
- #1 K192551 1ml Luer Slip or Luer Lock Syringe, Syringe…score 19.6 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K023752 | BD Integra SyringeSummary page 4…ate Regulation Number BD Integra Syringe 880.5860 FMF, MEG K023752 2/7/2003 Device Description The PowerPAKTM syringe is single-use, non-reusable, sterile safety syringe contain… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250847 | VaporShield | 2025 | 0 |
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 25 years and passes through 3 companies; a new generation was cleared every 20.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K250847 (Vault Paragon Group, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K023752.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MEG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEG
229in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEG
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MEG
148in 2025
MAUDE reports naming product code MEG, 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 | 8 | 100 | 0 | 21 |
| 2008 | 4 | 145 | 1 | 20 |
| 2009 | 2 | — | 0 | 26 |
| 2010 | 2 | — | 1 | 34 |
| 2011 | 5 | 113 | 0 | 34 |
| 2012 | 5 | 109 | 0 | 22 |
| 2013 | 1 | — | 5 | 27 |
| 2014 | 5 | 153 | 0 | 36 |
| 2015 | 7 | 253 | 1 | 51 |
| 2016 | 3 | 179 | 0 | 94 |
| 2017 | 3 | 130 | 0 | 181 |
| 2018 | 1 | — | 0 | 269 |
| 2019 | 4 | 249 | 0 | 497 |
| 2020 | 4 | 296 | 0 | 353 |
| 2021 | 5 | 152 | 0 | 541 |
| 2022 | 13 | 216 | 0 | 170 |
| 2023 | 5 | 229 | 0 | 120 |
| 2024 | 0 | — | 1 (1) | 112 |
| 2025 | 1 | — | 0 | 148 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The PowerPAK™ Syringe is indicated for general medical use in healthcare facilities by medical professionals for pediatric and adult population patients for aspiration and injection of fluids. Phlebotomy is not an intended use of this device. The PowerPAK™ Syringe is a 3mL syringe with a permanently attached needle system. Routes of Administration include subcutaneous, intradermal and intramuscular. Intravenous and Intraperitoneal are not intended uses…
Read the full statement (106 words)
The PowerPAK™ Syringe is indicated for general medical use in healthcare facilities by medical professionals for pediatric and adult population patients for aspiration and injection of fluids. Phlebotomy is not an intended use of this device.
The PowerPAK™ Syringe is a 3mL syringe with a permanently attached needle system. Routes of Administration include subcutaneous, intradermal and intramuscular. Intravenous and Intraperitoneal are not intended uses of this device.
The needle system contains an internal mechanism that retracts the needle inside the syringe after activation. Upon retraction, the needle is fully contained inside the syringe preventing reuse of the needle and accidental needlesticks during normal handling and disposal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220114: PowerPAK Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220114
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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