510(k) Report

510(k) · Cleared

Cleared

EZ-IO Intraosseous Infusion System

K132583510(k) TraditionalCleared Feb 11, 2014179-day reviewClass II21 CFR 880.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vidacare Corporation · FMI Needle, Hypodermic, Single Lumen

Cleared on Feb 11, 2014 as substantially equivalent to K091140 (Vidacare Corporation, 2009) and 5 other predicates after a 179-day review. Its family tree reaches back 7 generations to 1992.

Decided
Feb 11, 2014
Review
179 days
Class
Class II
Product code
FMI
Recalls
None
Predicates
6

Its longest line of descent runs back 7 generations to K915409 (1992). 14 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 2 other ancestors1998: 1 other ancestor1992: 1 other ancestor2005: 2 other ancestors2004: 1 other ancestorK915409 · Intraosseous Access Needle · Cook, Inc. · 1992K022415 · Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST · Waismed, Ltd. · 2002K043490 · PD-IO Disposable Intraosseous Infusion Needle · Vidacare Corporation · 2005K052195 · EZ-Mio Manual Driver · Vidacare Corporation · 2005K062956 · EZ-Mio, EZ-IO Distal Tibia · Vidacare Corporation · 2006K091140 · EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IO · Vidacare Corporation · 2009 · recalledK101026 · Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IO · Vidacare Corporation · 2010199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors K101026 · Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IO · Vidacare Corporation · 2010K091140 · EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IO · Vidacare Corporation · 2009 · recalledK062956 · EZ-Mio, EZ-IO Distal Tibia · Vidacare Corporation · 2006K052195 · EZ-Mio Manual Driver · Vidacare Corporation · 2005K043490 · PD-IO Disposable Intraosseous Infusion Needle · Vidacare Corporation · 2005K022415 · Bone Injection Gun (B.I.G.) for Pediatrics, Model 1ST · Waismed, Ltd. · 2002K915409 · Intraosseous Access Needle · Cook, Inc. · 1992−50
  1. Root · 7 generations backK915409 Intraosseous Access NeedleCook, Inc. · 1992
  2. 6 generations backK022415 Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd. · 2002
  3. 5 generations backK043490 PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation · 2005
  4. 4 generations backK052195 EZ-Mio Manual DriverVidacare Corporation · 2005
  5. 3 generations backK062956 EZ-Mio, EZ-IO Distal TibiaVidacare Corporation · 2006
  6. 2 generations backK091140 EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous…Vidacare Corporation · 2009 · Recalled
  7. 1 generation backK101026 Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IOVidacare Corporation · 2010
  8. This deviceK132583 EZ-IO Intraosseous Infusion SystemVidacare Corporation · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K915409Intraosseous Access NeedleCook, Inc.1992—
−6K022415Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd.2002—
−5K043490PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation2005—
−4K052195EZ-Mio Manual DriverVidacare Corporation2005—
−3K062956EZ-Mio, EZ-IO Distal TibiaVidacare Corporation2006—
−2K091140EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion…Vidacare Corporation20091
−1K101026Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IOVidacare Corporation2010—
0 (this device)K132583EZ-IO Intraosseous Infusion SystemVidacare Corporation2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199810
200410
200520
200620
FIG. 1 — Lineage of K132583, 1992–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K091140EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IO
Summary page 1
…o which we are claiming equivalence [807.92(a)(3)]: 510(k) number Trade or Proprietary or Manufacturer Model Name K091 140 EZ-MIO Distal Tibia, Vidacare Corporation EZ-10 Distal Tibia; EZ-…
Vidacare Corporation20091
*K101026Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IO
Summary page 1
…EZ-10 (formerly Vidaport) lntraosseous Infusion System; EZ-1O Humeral Head K101 026 Powered PD 10 Infusion Vidacare Corporation System; EZ-1O Humneral…
Vidacare Corporation2010—
*K981853Bone Injection Gun (B.I.G.) Device
Summary page 2
…October 30, 2013 510(k) number Trade or Proprietary or Manufacturer Model Name K981 853 Bone Injection Guntm Adult Waismed K062940 Proximal Tibia…
Waismed, Ltd.1998—
*K062940Bone Injection Gun (B.I.G.)
Summary page 2
…Trade or Proprietary or Manufacturer Model Name K981 853 Bone Injection Guntm Adult Waismed K062940 Proximal Tibia Humeral Head K915409 Cook Intracaseou…
Waismed, Ltd.2006—
*K915409Intraosseous Access Needle
Summary page 2
…del Name K981 853 Bone Injection Guntm Adult Waismed K062940 Proximal Tibia Humeral Head K915409 Cook Intracaseous Infusion Cook Medical Inc K913258 Needles Device Descrip…
Cook, Inc.1992—
*K913258Disposable Introsseous Infusion Needles
Our reading of the summary gave K913256, FDA’s number for Derma-Lase Ruby Laser - Model DLR-1 (Derma-Lase Co.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cook Intraosseous Infusion Needles”.
Cook, Inc.1992—

Also cleared against K091140: 1 other device →

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 22 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
  • 2 of the 14 ancestors have a recall of any class.
  • 1 other device also cites its predicate K091140.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · FMI

11in 2025

2007: 152008: 102009: 72010: 152011: 122012: 172013: 112014: 142015: 102016: 202017: 92018: 202019: 122020: 112021: 182022: 232023: 182024: 32025: 112026 (partial year): 12
2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007: 71 days median2008: 85 days median2009: 177 days median2010: 119 days median2011: 113 days median2012: 107 days median2013: 87 days median2014: 155 days median2015: 89 days median2016: 217 days median2017: 253 days median2018: 176 days median2019: 186 days median2020: 263 days median2021: 143 days median2022: 189 days median2023: 112 days median2024: 90 days median2025: 141 days median2026 (partial year): 119 days median
2007high 263 (2020) · low 71 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMI

1in 2024

2007: 22008: 42009: 32010: 792011: 52012: 12013: 12014: 32015: 12017: 162019: 52020: 32021: 72023: 22024: 12026 (partial year): 1, 1 Class I
2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007: 2082008: 1772009: 2632010: 2492011: 2402012: 2152013: 2552014: 2872015: 5672016: 9412017: 1,5472018: 2,3982019: 4,8962020: 4,2452021: 4,5322022: 4,8852023: 4,9862024: 4,0532025: 2,424
2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715712208
200810854177
200971773263
20101511979249
2011121135240
2012171071215
201311871255
2014141553287
201510891567
2016202170941
20179253161,547
20182017602,398
20191218654,896
20201126334,245
20211814374,532
20222318904,885
20231811224,986
202439014,053
20251114102,424
2026121191 (1)—

What is it indicated for?

The EZ-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and 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 as stated in the FDA summary.

Also cleared against K091140

1 other device cites the same predicate.

  • K101026Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IOVidacare Corporation · 2010

More from Vidacare Corporation

19 FDA decisions under this applicant name. See the company

  • K120661The T.a.L.O.N. Intraossous Infusion System by VidacreVidacare Corporation · 20121 recall
  • K113872The Oncontrol Bone Access and Bone Biopsy System by VidacareVidacare Corporation · 20122 recalls
  • K101026Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IOVidacare Corporation · 2010
  • K091140EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IOVidacare Corporation · 20091 recall
  • K081713Vertebral Access System by VidacareVidacare Corporation · 2008

Recent decisions in FMI

The FMI category page

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  • K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2026
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  • K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R…Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2026
  • K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd. · 2026

https://510kreport.com/device/K132583 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132583: EZ-IO Intraosseous Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132583

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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