510(k) · Cleared
ClearedNIO-I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waismed, Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Oct 7, 2019 as substantially equivalent to K043490 (Vidacare Corporation, 2005) and 1 other predicate after a 217-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Oct 7, 2019
- Review
- 217 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K915409 (1992). 7 ancestors in all, the oldest K913258 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK915409 Intraosseous Access NeedleCook, Inc. · 1992
- 3 generations backK022415 Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd. · 2002
- 2 generations backK043490 PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005
- 1 generation backK052195 EZ-Mio Manual DriverVidacare Corporation · 2005
- This deviceK190538 NIO-IWaismed, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK211395 NIO-IEinstein Works, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K211395NIO-IEinstein Works, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915409 | Intraosseous Access Needle | Cook, Inc. | 1992 | — |
| −3 | K022415 | Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST | Waismed, Ltd. | 2002 | — |
| −2 | K043490 | PD-IO Disposable Intraosseous Infusion Needle | Vidacare Corporation | 2005 | — |
| −1 | K052195 | EZ-Mio Manual Driver | Vidacare Corporation | 2005 | — |
| 0 (this device) | K190538 | NIO-I | Waismed, Ltd. | 2019 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K043490 | PD-IO Disposable Intraosseous Infusion NeedleSummary page 4…on of Predicate a. Primary Predicate VidaCare Corporation's PD-IO, Disposable Intraosseous Infusion Needle and Handle cleared under 510(k) number K043490 on February 18, 2005. b. Secondary Predicate VidaCare Corporation's EZ-MIO Manual Driver cleared under 510(k)… | 2005 |
| * | K052195 | EZ-Mio Manual DriverSummary page 4…510(k) number K043490 on February 18, 2005. b. Secondary Predicate VidaCare Corporation's EZ-MIO Manual Driver cleared under 510(k) number K052195 on November 2, 2005. 4. Identification of Subject Device a. Regulatory Information Regulation Name: Hypodermic… | 2005 |
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 |
|---|---|---|---|
| K211395 | NIO-I | 2021 | 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 27 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K211395 (Einstein Works, LLC, 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K043490.
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-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 as stated in the FDA summary.
https://510kreport.com/device/K190538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190538: 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/K190538
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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