510(k) · Cleared
Recalled · Class I · 2026Piper GO-IO Intraosseous Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Piper Access, LLC · FMI Needle, Hypodermic, Single Lumen
Cleared on Nov 13, 2019 as substantially equivalent to K141117 (Vidacare, LLC, 2014) after a 112-day review. Its family tree reaches back 1 generation to 2014. 2 of the 4 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Nov 13, 2019
- Review
- 112 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K141117 (2014). 2 later devices descend from it, 1 citing it directly. 2 of the 4 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK141117 EZ-IO Intraosseous Infusion SystemVidacare, LLC · 2014 · Recalled
- This deviceK191976 Piper GO-IO Intraosseous Infusion SystemPiper Access, LLC · 2019
- Descendant · cites it directly · 1 of its ownK203193 BD Intraosseous Infusion SystemBard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] · 2021 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK223198 BD Intraosseous Vascular Access System EMS Powered Driver (D001003)Bard Access Systems · 2022
Class I recalls in this family
- K203193 BD Intraosseous Infusion Systemcites it directly · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K141117 | EZ-IO Intraosseous Infusion System | Vidacare, LLC | 2014 | 3 |
| 0 (this device) | K191976 | Piper GO-IO Intraosseous Infusion System | Piper Access, LLC | 2019 | — |
| +1 | K203193 | BD Intraosseous Infusion System | Bard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] | 2021 | Class I |
| +2 | K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003) | Bard Access Systems | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 1 |
| 2022 | 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.
2 devices in this family have a Class I recall. 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 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 |
|---|---|---|---|
| * | K141117 | EZ-IO Intraosseous Infusion SystemSummary page 4…gulation: 21 CFR 880.5570 Product Code: FMI Panel: General Hospital Predicate Device 510(k): K141117 (Clearance Date July 8, 2014) Trade Name: EZ-IO® Intraosseous Infusion System Manufacturer: Arr… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203193 | BD Intraosseous Infusion System Class I | 2021 | 1 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2026 | Class I | Z-2872-2026 | Component change control | After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove obturator, due to… |
| Jun 20, 2022 | Class I | Z-1397-2022 | Process change control | BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K203193BD Intraosseous Infusion SystemBard Access Systems, Inc (Bas)[Wholly-Owned Subsidiary of Bd] · 2021 · Cites it directly · ◆ in the 2021 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The Piper GO-IO® Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
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/K191976 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191976: Piper GO-IO Intraosseous Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191976
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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