510(k) · Cleared
ClearedNIO-I
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 Jul 28, 2021 as substantially equivalent to K190538 (Waismed, Ltd., 2019) after an 84-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Jul 28, 2021
- Review
- 84 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K915409 (1992). 8 ancestors in all, the oldest K913258 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK915409 Intraosseous Access NeedleCook, Inc. · 1992
- 4 generations backK022415 Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd. · 2002
- 3 generations backK043490 PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005
- 2 generations backK052195 EZ-Mio Manual DriverVidacare Corporation · 2005
- 1 generation backK190538 NIO-IWaismed, Ltd. · 2019
- This deviceK211395 NIO-IEinstein Works, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915409 | Intraosseous Access Needle | Cook, Inc. | 1992 | — |
| −4 | K022415 | Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST | Waismed, Ltd. | 2002 | — |
| −3 | K043490 | PD-IO Disposable Intraosseous Infusion Needle | Vidacare Corporation | 2005 | — |
| −2 | K052195 | EZ-Mio Manual Driver | Vidacare Corporation | 2005 | — |
| −1 | K190538 | NIO-I | Waismed, Ltd. | 2019 | — |
| 0 (this device) | K211395 | NIO-I | Einstein Works, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K190538 | NIO-ISummary page 4…2. Date of Preparation July 28, 2021 3. Identification of Predicate Waismed LTD's NIO-I, Intraosseous infusion device cleared under 510(k) number K190538 on July 10, 2019. 4. Identification of Subject Device a. Regulatory Information Regulation Name: Needle, Inter… | 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 29 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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-I is an intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.
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/K211395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211395: NIO-I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211395
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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