510(k) · Cleared
ClearedIntraosseous infusion device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Einstein Works, LLC · FMI Needle, Hypodermic, Single Lumen
Cleared on Oct 23, 2019 as substantially equivalent to K160805 (Waismed, Ltd., 2016) and 1 other predicate after a 166-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Oct 23, 2019
- Review
- 166 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K981853 (1998). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK981853 Bone Injection Gun (B.I.G.) DeviceWaismed, Ltd. · 1998
- 5 generations backK032885 Vidaport Intraosseous Infusion SystemVidacare Corporation · 2004
- 4 generations backK052408 EZ-IOVidacare Corporation · 2005 · Recalled
- 3 generations backK062940 Bone Injection Gun (B.I.G.)Waismed, Ltd. · 2006
- 2 generations backK142086 Nio -Intraosseous DeviceWaismed, Ltd. · 2014 · Recalled
- 1 generation backK160805 NIO-PWaismed, Ltd. · 2016 · Recalled
- This deviceK191258 Intraosseous infusion deviceEinstein Works, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981853 | Bone Injection Gun (B.I.G.) Device | Waismed, Ltd. | 1998 | — |
| −5 | K032885 | Vidaport Intraosseous Infusion System | Vidacare Corporation | 2004 | — |
| −4 | K052408 | EZ-IO | Vidacare Corporation | 2005 | 1 |
| −3 | K062940 | Bone Injection Gun (B.I.G.) | Waismed, Ltd. | 2006 | — |
| −2 | K142086 | Nio -Intraosseous Device | Waismed, Ltd. | 2014 | 1 |
| −1 | K160805 | NIO-P | Waismed, Ltd. | 2016 | 1 |
| 0 (this device) | K191258 | Intraosseous infusion device | Einstein Works, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 FMI? 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? (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 |
|---|---|---|---|
| * | K160805 | NIO-PSummary page 4…E: Primary Predicate: WaisMed LTD, NIO- P (Pediatric) Intraosseous Infusion Device (K160805) Secondary Predicate: Einstein Works, L.L.C. NIO- A (Adult… | 2016 |
| * | K182770 | Adult Intraosseous Infusion DeviceSummary page 4…Secondary Predicate: Einstein Works, L.L.C. NIO- A (Adult) Intraosseous Infusion Device (K182770) DEVICE DESCRIPTION: The Einstein Works NIO Pediatric (NIO- P) Intraosseous Infusion Device permits intraosseous access thro… | 2019 |
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 21 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 7 ancestors have a recall of any class.
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 NIO-P for pediatric is intended to provide Intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients in age 3-12 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191258: Intraosseous infusion device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191258
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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